First Quality Jobs in Usa

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Paragonix Technologies markets organ transportation devices that safeguard organs during the journey between donor and recipient patients. Our devices incorporate clinically proven and medically trusted hypothermic preservation techniques in a novel suspension system to provide unprecedented physical and thermal protection. Our product portfolio spans cardiac, thoracic, and abdominal preservation devices to improve donor organ quality and extend donor organ transport time. Paragonix also markets transplant services and organ screeningto the transplant community.

Position Overview: The Design Quality Engineer will play a crucial role in ensuring the quality and compliance of Paragonix's medical device products throughout the design and development lifecycle. The successful candidate will collaborate closely with cross-functional teams, including R&D, manufacturing, regulatory affairs, and quality assurance, to drive excellence in design control processes.

Primary responsibilities/authority will include:

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• Design Control Compliance: Implement and maintain design control processes in accordance with applicable regulatory standards (e.g., ISO 13485, ISO 14971, FDA QSR, MDR) to ensure the development of safe and effective medical devices.
  
• Risk Management: Lead and contribute to risk management activities throughout the design process, including the identification, assessment, and mitigation of potential risks. Work closely with the R&D team to integrate risk management into the design process.
  
• Failure Analysis: Assist in Post-Market Surveillance (PMS) initiatives, including failure investigation, record review, and data trending.
  
• Quality Planning: Develop and execute quality plans for new product development projects, outlining quality objectives, deliverables, and verification/validation activities.
  
• Design Input and Output:
  
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  • Review and approve design inputs to ensure they are clear, complete, and aligned with user needs and regulatory requirements.
    
  • Validate that design outputs meet the specified design input requirements.
    
  
  
  
• Change Control: Manage design changes by assessing their impact on product quality, ensuring proper documentation, and obtaining necessary approvals.
  
• Verification and Validation:
  
  • 
    
  • Develop and execute protocols for design verification and validation strategies and acceptance criteria.
    
  • Collaborate with testing teams to ensure thorough testing of product designs.
    
  
  
  
• Collaboration: Work closely with cross-functional teams, including R&D, manufacturing, regulatory affairs, and quality assurance, to facilitate effective communication and collaboration throughout the product development process.
  
• Regulatory Compliance: Stay abreast of relevant regulations and standards and ensure that product designs comply with applicable requirements. Support regulatory submissions as needed.
  
• Continuous Improvement: Identify opportunities for process improvements within the design control system and contribute to the development and implementation of best practices.
  

Required Qualifications:

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• Bachelor's degree in engineering or a related field; advanced degree preferred.
  
• Minimum of 1-3 years of experience in a quality engineering role in the medical device industry.
  
• In-depth knowledge of design control processes, risk management, and quality management systems (ISO 13485, ISO 14971, FDA QSR).
  
• Strong technical skills related to product quality including VOE translation to Design Specs, Human Factors, CTQ Cascades, Design Characterization, Verification / Validation, Test Method Validation, Process Validation, Inspection Techniques and Statistics.
  
• Strong understanding of regulatory requirements for medical devices (FDA, EU MDR, etc.).
  
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions.
  
• DFSS or DMAIC Black Belt Certified, ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) certification is a plus.
  

Other Requirements:

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• Electrical and mechanical background strongly preferred.
  
• Experience creating and analyzing charts in Minitab, JMP, or equivalent software a plus.
  
• Knowledge of Six Sigma, Lean, SPC, ASQ and/or ISO process controls a plus.
  
• Computer proficiency in MS office (specifically Excel).
  
• Effective verbal and excellent technical writing skills.
  
• Excels at generating and maintaining organized and accurate records.
  
• Excellent oral and written communication skills in English.
  
• Able to travel domestically and internationally as required (

ModernaTX, Inc. seeks a Supervisor, Quality Assurance Operations for its Norwood, Massachusetts location.

Heres What Youll Do:

• On behalf of a global biotechnology company, maintain responsibility for quality oversight of clinical operations.
• Responsible for ensuring quality oversight of mRNA platform in clinical manufacturing.
• Provide real-time quality leadership and on-the-floor operational support for the clinical manufacturing team.
• Make quality decisions that may impact operations, ensuring appropriate escalation.
• Coordinate training, professional development, and growth of the Clinical Quality Assurance team.
• Monitor process operations to ensure compliance with procedures and specifications.
• Demonstrate knowledge of standard manufacturing compliance, quality disposition, and quality system review.
• Identify risks and communicate gaps for quality and GMP process/systems.
• Enforce adherence to current Good Manufacturing Practices (cGMPs), standard operating procedures (SOPs), and manufacturing documentation.
• Partner with manufacturing and support management teams to focus on site initiatives.
• Oversee and perform review of executed electronic and paper batch record documentation.
• Support product disposition.
• Supervise approximately 4 Quality Assurance Operations Associates/Specialists.

Heres What Youll Bring to the Table:

Minimum requirements:

• Requires a minimum of a Bachelors degree, or foreign equivalent, in Chemistry, Chemical Laboratory Technology, Manufacturing Engineering or a related field and 4 years of experience in the position offered, or as a Quality Assurance Specialist, Sr. Specialist, or related position.
• Alternatively, employer will accept an Associates degree in the stated fields and 5 years of experience in the stated positions.
• 4 years of experience must include:
  • Quality assurance in early and late-stage clinical products applying Good Manufacturing Practices (cGMP) and FDA guidelines;
  • Leveraging knowledge of Quality Management Systems (QMS) to review and approve deviations, change controls, and corrective and preventive actions (CAPAs);
  • Collecting, analyzing, and interpreting data related to quality metrics, defect rates, and process performance indicators; and
  • Performing risk assessments and implementing mitigation strategies.
• May telecommute up to 2 days per week.

Apply at https:///en-US/M_tx (Job ID: R17937) or email resume and cover letter to with subject line: R17937.

At Moderna, we believe that when you feel your best, you can do your best work. Thats why our US benefits and global well-being resources are designed to support youat work, at home, and everywhere in between.

• Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Lifestyle Spending Accounts to personalize your well-being journey
• Family planning and adoption benefits
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investment opportunities
• Location-specific perks and extras

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

Our Working Model

As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.

Moderna is a smoke-free, alcohol-free, and drug-free work environment.

Equal Opportunities

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Accommodations

Were focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at .

Export Control Notice

This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicants ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.

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• Establish and execute Audit/Surveillance Plans for SUBSAFE / Level I / Corporate Component Repair Program (CCRP), Modernization and Manufacturing contract work.
  
• Establishes basic Test and Inspection Plans for projects. Perform in-process work surveillances, safety surveillances and conduct final work-package review after work-completion.
  
• Performs internal audit of to monitor compliance with company procedures and performs external audits to evaluate supplier suitability for use. Develop trend analysis and reports.
  
• Prepares Corrective Action Requests, and Preventative Action requests as related to production work to ensure compliance with established policies, procedures and work instructions.
  
• Assists Program Managers, Project Managers, and Supervisors/Foreman in the understanding of NAVSEA Standard Item and other customer related requirements to ensure work is conducted accurately and safely.
  
• Assists in the development of written procedures for Safety, Hull, Mechanical, and Electrical Trades work and tasks
  
• Monitors compliance with company Quality and Safety Management Systems, Workmanship standards and Customer requirements.
  
• Develops safety, quality control and inspection procedures for inclusion in test and inspection plans for production Work-Packages.
  
• Defines test standards and specifies test equipment associated with requirements established in test and inspection plans.
  
• Schedules and Conducts Safety/Quality Assurance inspections, Audit and Surveillances.
  
• Performs Audits and evaluations of Suppliers/Subcontractors.
  
• Works with customer QA/Safety representatives to coordinate inspection and acceptance activities.
  
• Reviews QA/Safety control requirements with customer representative to assure compliance with requirements.
  
• Reviews contractually required quality/safety documentation for accuracy and completeness for project/job/contract completion.
  
• Maintain OQE records retention.
  

• High School GED Diploma or equivalent and specialized training and certifications in Quality Assurance with 10 years total waterfront experience with training and experience in Quality Assurance to include minimum 7 years extensive SUBSAFE/SOC Shipboard/CCRP quality oversight experience.

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• Bachelors Degree and 4 years waterfront SUBSAFE/SOC Shipboard/CCRP quality experience.
  
• Bachelor's Degree may be substituted with a completed Maritime Trade School / Apprenticeship with 5 years waterfront Quality Assurance experience OR 6 years' military service with specialized training and experience in Quality Assurance to include minimum 5 years extensive SUBSAFE/SOC Shipboard/CCRP quality oversight experience.
  

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• Must be able to obtain and maintain access to U.S Military bases and shipyards for performance of job duties.
  
• Must be able to obtain and maintain Secret Security Clearance.
  
• Pursuant to the various government contractual requirements, all applicants must be a U.S. Citizen.
  

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• Knowledge and experience in Submarine systems within SUBSAFE / SOC Boundary to include repair, overhaul, inspection and testing of shipboard systems.
  
• Knowledge and experience in Submarine Corporate Component Repair Program Assets (valves, actuators, hydraulic cylinders, etc.) to include repair, overhaul, inspection and testing of CCRP assets.
  
• Knowledgeable in shipyard, maritime, and commercial work practices, quality assurance, safety, Metal-work and contracting methods.
  
• Knowledge of Navy ship repair processes and procedures.
  
• Knowledge of OSHA Regulations for Shipyard Employment, NAVSEA Standard Items, Joint Fleet Maintenance Manual (JFMM), NAVSHIPS Tech Manuals (NSTM), SUBSAFE, DSS-SOC and DOD Standards, Military Specifications, Performance Standards, and other customer related specifications and standards
  
• Knowledgeable in all aspects of workplace Safety.
  
• Knowledge of the practical application of engineering science and technology. This includes applying principles, techniques, procedures, and equipment to the design and production of various goods and services.
  
• Knowledge of arithmetic, algebra, geometry, calculus, statistics, and their applications.
  
• Knowledge of raw materials, production processes, quality control, costs, and other techniques for maximizing the effective fabrication or manufacture and distribution of products.
  

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• Able to conduct audits and surveillances.
  
• Able to conduct tests and inspections of products, services, or processes to evaluate quality or performance.
  
• Effective written and oral communication skills.
  
• Able to use logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
  
• Effective interpersonal skills and able to lead/teach others.
  
• Effective problem solving skills. Provides sound judgment and decision.
  
• Proficient in Microsoft Office programs including but not limited to Word, Excel, Power Point and Access
  

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• Able to understand written sentences and paragraphs in work related documents.
  
• Able to read structural, mechanical and electrical drawings.
  
• Able to anticipate problem and apply general rules to specific problems to produce answers that make sense.
  
• Able to generate or use different sets of rules for combining or grouping things in different ways.
  

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• Must be able to physically access ships, small craft, and submarines.
  
• Able operate in: confined Spaces, noisy environment, heavy Industrial conditions, high traffic areas, office environment, meetings and multiple locations.
  
• Able to Remain calm in: Stressful situations including; high pressure production schedule, strict workmanship requirements, customer interface, regulatory requirements.
  
• Able to lift, carry and move objects at least 25 lbs. in weight.
  
• Visual acuity and manual dexterity.
  

L3Harris is dedicated to recruiting and developing high-performing talent who are passionate about what they do. Our employees are unified in a shared dedication to our customers' mission and quest for professional growth. L3Harris provides an inclusive, engaging environment designed to empower employees and promote work-life success. Fundamental to our culture is an unwavering focus on values, dedication to our communities, and commitment to excellence in everything we do.

L3Harris is the Trusted Disruptor in defense tech. With customers' mission-critical needs always in mind, our employees deliver end-to-end technology solutions connecting the space, air, land, sea and cyber domains in the interest of national security.

#LI-KG1

Job Title: Manufacturing Quality Engineer

Job Location: Camden, NJ

Schedule: 9/80

Job Description:

We are seeking a highly motivated Quality Engineer (QE) to join our Quality team. This role is responsible for ensuring that supplied materials and components meet internal and external requirements for quality and compliance. The ideal candidate will have hands-on experience with SAP, a strong understanding of outbound logistics and shelf life labeling, and a working knowledge of aerospace quality clauses and industry standards.

Essential Functions:

• Lead quality assurance activities from onboarding through lifecycle support.
• Perform audits, assessments, and root cause investigations for non-conformances.
• Collaborate with suppliers to ensure compliance with customer quality clauses and AS9100/ISO9001 standards.
• Review and validate shelf life labels, certifications, and documentation for outbound shipments.
• Monitor performance and implement corrective actions using 8D, 5-Whys, or similar tools.
• Utilize SAP to manage supplier data, track inspections, and process quality notifications.
• Coordinate with purchasing, logistics, and engineering teams to resolve supply chain quality issues.

Qualifications:

• 3+ years of experience in a Supplier Quality, Manufacturing Quality, or related role in the aerospace or defense industry.
• Proficiency in SAP for quality and supply chain processes.
• Familiarity with outbound logistics, labeling requirements, reviewing CoC's, and shelf life management.
• Strong understanding of aerospace quality clauses, contracts, and regulatory requirements (e.g., FAA, EASA, DoD).
• Excellent communication, organizational, and problem-solving skills.
• ASQ Certified Quality Engineer (CQE) or similar certification is a plus.

In compliance with pay transparency requirements, the salary range for this role is $51,132.00-128,970.00. This is not a guarantee of compensation or salary, as final offer amount may vary based on factors including but not limited to experience and geographic location. L3Harris also offers a variety of benefits, including health and disability insurance, 401(k) match, flexible spending accounts, EAP, education assistance, parental leave, paid time off, and company-paid holidays. The specific programs and options available to an employee may vary depending on date of hire, schedule type, and the applicability of collective bargaining agreements.

L3Harris Technologies is proud to be an Equal Opportunity Employer. L3Harris is committed to treating all employees and applicants for employment with respect and dignity and maintaining a workplace that is free from unlawful discrimination. All applicants will be considered for employment without regard to race, color, religion, age, national origin, ancestry, ethnicity, gender (including pregnancy, childbirth, breastfeeding or other related medical conditions), gender identity, gender expression, sexual orientation, marital status, veteran status, disability, genetic information, citizenship status, characteristic or membership in any other group protected by federal, state or local laws. L3Harris maintains a drug-free workplace and performs pre-employment substance abuse testing and background checks, where permitted by law.

Please be aware many of our positions require the ability to obtain a security clearance. Security clearances may only be granted to U.S. citizens. In addition, applicants who accept a conditional offer of employment may be subject to government security investigation(s) and must meet eligibility requirements for access to classified information.

By submitting your resume for this position, you understand and agree that L3Harris Technologies may share your resume, as well as any other related personal information or documentation you provide, with its subsidiaries and affiliated companies for the purpose of considering you for other available positions.

L3Harris Technologies is an E-Verify Employer. Please click here for the E-Verify Poster in English or Spanish. For information regarding your Right To Work, please click here for English or Spanish.

Senior Air Quality Consultant

Company: Trinity Consultants

Location: Ann Arbor, MI

About Trinity Consultants:

Trinity Consultants is a leading environmental consulting firm that specializes in air quality, water quality, waste management, and more. We combine regulatory expertise, technical proficiency, and creative thinking to deliver high-quality solutions for our clients across various industries. Role Overview: As a Senior Air Quality Consultant, you will lead and manage air quality assessment, permitting, and compliance projects. Your responsibilities will include leading the development of air quality permit applications, conducting compliance audits, working with clients to enhance compliance and sustainability practices, and mentoring staff to become effective consultants. Additionally, you will conduct environmental impact assessments and provide expert advice on air quality regulations and compliance.

Key Responsibilities:

•Lead and manage air quality assessment, permitting, and monitoring projects.

•Collect and analyze data related to air quality.

•Prepare comprehensive reports and recommendations.

•Conduct environmental impact assessments.

•Provide expert advice on air quality regulations and compliance.

•Collaborate with clients, regulatory agencies, and internal teams.

Qualifications:

•Bachelor’s degree in environmental science, engineering, or a related field.

•Minimum of 5-7years of air quality experience in industry or consulting.

•Strong knowledge of air quality regulations and permitting processes.

•Understanding of air dispersion modeling.

•Experience with Michigan Regulations & Compliance

•Excellent communication and project management skills.

•Professional certifications (e.g., CEP, PE, CIH) are a plus.

Why Join Trinity Consultants?

•Work on impactful projects that contribute to environmental sustainability.

•Collaborate with a diverse team of experts.

•Enjoy a supportive and dynamic work environment.

•Opportunity for professional growth and development.

If you’re passionate about air quality and want to make a difference, we’d love to hear from you!

Apply now and be part of our mission to enhance regulatory compliance while maximizing operational flexibility. Feel free to send your resume to include in subject "Senior Consultant- Ann Arbor"

Our team members are the heart of what makes us better.

At Hackensack Meridian Health we help our patients live better, healthier lives — and we help one another to succeed. With a culture rooted in connection and collaboration, our employees are team members. Here, competitive benefits are just the beginning. It's also about how we support one another and how we show up for our community.

Together, we keep getting better - advancing our mission to transform healthcare and serve as a leader of positive change.

The Manager of Patient Safety and Quality acts in conjunction with the Director of Patient Safety & Quality to provide leadership for quality & safety improvement initiatives. Collaborates with Hackensack Meridian Health (HMH) initiative-focused groups, clinical transformation services and quality councils to achieve transformational and sustainable outcome improvements using project/program management, process and system mapping, reliability science data driven strategies, evidence based best practices and quality improvement strategies. Provides ongoing support, instruction, and leadership to meet and exceed all accreditation standards, and to ensure ongoing readiness for accreditation throughout all accredited programs. Works with the Director Patient Safety and Quality to respond to and coordinate investigation by the Joint Commission, Department of Health (DOH) and other external regulatory agencies.

A day in the life of a Manager of Patient Safety and Quality at Hackensack Meridian Health includes:

• Orient and mentor new Department of Patient Safety and Quality team members. Provides feedback to Director of Patient Safety and Quality on team member performance evaluations
• Provide expert knowledge, leadership and mentoring in patient safety & quality initiatives utilizing safety and high reliability science.
• Monitor standards of practice to ensure compliance with codes of internal and external regulatory and accrediting agencies including: a. The Joint Commission b. NJ State and Federal Codes (i.e.: DOH, OSHA) c. Professional review organizations
• Chair organizational level committees/councils (i.e. Regulatory Steering Committee, Performance Improvement Committee).
• Facilitates/coordinates regulatory activities throughout all accredited programs.Collaborates with staff, physicians, and administration to ensure successful regulatory surveys.
• Facilitate patient safety and environment of care rounds with interprofessional collaboration with utilization of the Joint Commission AMP monitoring tool.
• Lead onsite regulatory surveys to respond to and coordinate investigation by the Joint Commission, DOH and other external regulatory agencies.
• Develops and implements hospital wide training to maintain compliance with Joint Commission and other regulatory standards.
• Facilitate and lead highly functioning teams organized around quality & safety initiatives.
• Identify improvement priorities specific to each HMH initiative-focused improvement work, clinical transformation service, or quality council based on evidence based practice, taking into consideration regulatory requirements and accrediting agencies such as CMS, Pay for Performance, The State of New Jersey Department of Health, and The Joint Commission.
• Bring safety and quality events, concerns and needs to the local morning safety huddle.
• Encourage event reporting and transparency related to events, concerns, needs, processes to identify precursor and safety events.
• Identify & implement data driven strategies to ensure team's success.
• Utilize the Quality dashboards to drive improvements by the HMH initiative-focused improvement work, clinical transformation service, or quality council.
• Strategize with personnel at all levels to develop and coordinate patient safety programs.
• Create and maintain timely and thorough progress reports that include key driver diagrams, run charts, Agile methods and PDSA testing documentation.
• Engage all levels of caregivers and staff in advancing patient safety through HRO training, quality initiatives addressing small wins and when designing system improvement.
• Develop metrics and report key quality & safety metrics to accurately demonstrate improvement in safety & quality across the medical center and network.
• Provide timely, actionable feedback and reports to clinical, administrative and support staff on all safety & quality initiatives.
• Ensure appropriate referral and follow up for events including escalation for regulatory reporting. Increase transparency, reinforce high reliability and advance the safety culture by participating in and facilitating safety huddles, patient safety activities, just culture reinforcement and shared learning. Facilitate the NPSF RCA-2 process as needed.
• Effective trend analysis of performance data with comparison over time to internal and external benchmarks to identify improvement opportunities, and progress.
• Attend root cause analysis meetings as specific to HMH initiative-focused group, clinical transformation service, or quality council focus area.
• Direct patient and team member safety by identification of actual or potential safety issues. Advance & enhance professional growth and development through seminars, workshops and professional networking opportunities to maintain and extend expertise.
• Other duties and/or projects as assigned
• Adheres to HMH Organizational competencies and standards of behavior.

Education, Knowledge, Skills and Abilities Required:

• Bachelor's degree in Nursing, Healthcare or health science field or other relevant area of study.
• Minimum of 5 or more years of experience in healthcare quality, patient safety, and regulatory.
• Performance Improvement experience.
• Understanding of the Joint Commission and regulatory standards.
• Excellent written and verbal communication skills.
• Proficient computer skills that include but are not limited to Microsoft Office and/or Google Suite platforms.

Education, Knowledge, Skills and Abilities Preferred:

• Master's degree in nursing, health care or health science.

Licenses and Certifications Required:

Notice: MCRA’s Talent Solutions division works to unite top talent with opportunities on our clients’ teams. This posting is not for a position directly at MCRA, but rather for a position with a MCRA client that our team is helping to recruit and fill.

MCRA's client, a commercial-stage medical device company specializing in designing, developing, and marketing orthopedic fracture repair and stabilization products, is in search of a Director of Quality and Regulatory Affairs to provide support across Regulatory, Quality Assurance, Operations, and Research & Development (R&D).

Primary Roles:

• Is a key member of the senior leadership, and is responsible for the successful operation of the company's quality and regulatory systems. Essential functions include the development, implementation, maintenance, and improvement of company-wide quality and regulatory systems, integrating continuous improvement activities.
• Serves as our clients Management Representative under ISO and FDA requirements, and takes the lead role in ensuring that the quality management system is efficient, effectively implemented and ensures compliance with the requirements of applicable regulatory agencies. Responsible for the generation and maintenance of our client's Quality systems, with direct oversight for the processes for Complaints Management, CAPA, Risk Management, Post-Market Surveillance, and Regulatory Reporting.
• Is responsible for leading the resolution of quality and compliance issues within the business and provide routine quality feedback and leadership to cross-functional groups
• Serves as the official correspondent to Competent Authorities (e.g. FDA, EU countries, etc) as well as Notified Body. Responsible for maintaining compliance registrations and device listings.
• Ensuring compliance with FDA and other applicable international regulations and requirements for the design, development, distribution, and maintenance of medical devices and provide general regulatory support to the organization

Responsibilities:

Quality Systems

• Provide operational leadership in planning and management of quality system activities to maintain appropriate QMS certification
• Responsible for leading and interfacing with any Notified Bodies or Competent Authorities during inquiries or facility inspections by such organizations
• Acts as lead in all product complaint and recall campaigns.
• Responsible for interfacing with and following up with any Customers regarding complaints
• Responsible for Supplier Quality assurance program
• Responsible for Measurement, analysis and improvement programs, including quality trending, CAPA system, and the Internal Quality Audit program for our client.
• Leads the Management Review process

Quality Engineering

• Ensures all inspection and quality plans are statistically sound and can ensure quality levels that exceed requirements
• Ensures all device history records are complete and reviewed prior to release of product
• Assist suppliers by providing information to enable process improvements
• Ensure all manufactured products are conforming to FDA Quality System, ISO 13485, MDD, and MDR
• Supports the engineering staff with PPQA activities, validations, and statistical analysis of new products and processes
• Leads Risk Management and Post-Market Surveillance activities

Regulatory Affairs

• Develop and implement global regulatory and compliance strategies to:
• Ensure all products designed, manufactured and/or shipped meet all regulatory, corporate and customer requirements for quality, safety and efficacy;
• Ensure proper and timely preparation and maintenance of national and international new product submissions, registration/licensing renewals, product listings, post market surveillance reports, import and export documents, safety testing, and other national and international requirement
• Optimize and focus on quality during the design and change control processes for both new and existing products;
• Ensure all advertising and promotion materials conform to applicable FDA, EU, and, where applicable, other country regulations.
• Responsible for the CE Mark approval process for all products, and Technical File generation and maintenance
• Responsible for writing Letters to File as required
• Participates in the development and writing of 510(k) submissions with the management team utilizing external resources as required
• Responsible for external agency reporting

Education:

• Bachelor’s Degree in Engineering or Natural Science preferred, coupled with approximately 10 years of combined experience in QA / RA in the medical devices industry; experience regarding medical device design, development and manufacturing regulations, especially 21 CFR Part 820 Quality System Regulation, the MDD and MDR Directives, as well as ISO 13485 requirements. 5 years of experience managing supervisory personnel and contributing toward the development of department strategies.

Experience/ Skills:

• Ability to build efficient quality assurance systems; including electronic document and record control, CAPA, NCR, complaint, training, metrics
• Demonstrated ability to write, review, execute and critique validation protocols, investigation plans, root cause analyses, NCRs, CAPAs, complaints, trend report
• Has experience with applying ISO 14971 principles to medical devices throughout all stages of the product's lifecycle.
• Demonstrated leadership skills and team building skills, inspires others toward continuous quality improvement
• Able to solve complex quality, technical, managerial or budgeting problems
• Readily adapts to changing priorities, effectively manages own time and direct reports to ensure tasks, projects are completed on time to meet growth objectives. Adjusts easily and readily to a fast-paced work environment
• Working knowledge of data acquisition, analysis and statistical software
• Demonstrated ability to manage multiple projects and technical personnel simultaneously
• Successful oral and written communication skills, business acumen and assertive decision-making ability
• Excellent computer skills, including MS Office proficiency

NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as to meet the ongoing needs of the organization.

MCRA, LLC is an equal opportunity/Affirmative Action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

Who We Are:

Delta, founded in 1971, is a global leader in switching power supplies and thermal management products with a thriving portfolio of smart energy-saving systems and solutions in the fields of industrial automation, building automation, telecom power, data center infrastructure, EV charging, renewable energy, energy storage and display, to nurture the development of smart manufacturing and sustainable cities. As a world-class corporate citizen guided by its mission statement, “To provide innovative, clean and energy-efficient solutions for a better tomorrow,” Delta leverages its core competence in high-efficiency power electronics and its ESG-embedded business model to address key environmental issues, such as climate change. Delta serves customers through its sales offices, R&D centers and manufacturing facilities spread over close to 200 locations across five continents. Delta has 158 sales offices, 72 R&D centers and 48 manufacturing facilities worldwide.

Throughout its history, Delta has received various global awards and recognition for its business achievements, innovative technologies, and dedication to ESG. Since 2011, Delta has been listed on the DJSI World Index of Dow Jones Sustainability™ Indices for 11 consecutive years. In 2021, Delta was also recognized by CDP with leadership level ratings for its substantial contribution to climate change and water security issues and named Supplier Engagement Leader for its continuous development of a sustainable value chain.

What you would be doing:

Ensures manufacturing and assembly processes/procedures utilized by Contract Manufacturers meet product quality and reliability requirements.

Tracks ongoing quality and yield performance to drive improvement activities.

Evaluates new product designs for manufacturability.

Assists Contract Manufacturers with problem identification, root cause analysis, and corrective action identification, verification, and implementation.

Implements quality plans for rapidly transitioning products into manufacture.

Determines acceptability of product from subcontractors and internal operations.

Supports quality system development and implementation to applicable codes and standards such as ISO9001, etc.

Performs, documents and track results of internal audits.

Generates, evaluates and tracks corrective action requests.

Inspects and evaluates material and product quality according to internal process and procedures.

Assists in training of company personnel.

Interfaces with customers for quality activities

.

What we require (Skills and Background):

• Bachelor’s degree in engineering, Electronics or related discipline or equivalent desired
• Four to six years of previous quality assurance experience in the electronics or power industry required.
• Previous experience working with an ISO-9001 quality assurance program required
• Automotive background experience (IATF 16949 Automotive Quality Management System in particular) to support EV business.
• Core Quality and Engineering Tools (QMS, PPAP, APQP, FMEA, SPC, MSA, QCP, PMP)
• Quality metrics and driving metrics improvement (Yield, Cpk, GR&R, Scrap, MRB, DPPM
• Knowledge of statistical techniques and demonstrated ability to review and approve test plans, qualification reports, drawings, documents
• Quality Control Analysis; conducting tests and inspections of products, services, or processes to evaluate quality or performance.
• Monitoring/ Assessing performance of yourself, other individuals, or organizations to make improvements or take corrective action.
• Demonstrated advance proficiency with computer software to include MS Office (Word and Excel) and e-mail

Desired Skills:

Auditor or Lead Auditor Certification or Certified Quality Engineer is preferred.

ISO14001:2015 Environmental Management Systems, ISO 45001 Health, and Safety Management is a plus.

Delta SQMS (Smart Quality Management System) experience

Smart IQC

MES (Manufacturing Execution System)

What you will experience at Delta:

You will be joining one of the world’s leaders in technology as they grow their presences in North America. This role offers a competitive salary package, comprehensive benefits, and the opportunity to work with a dynamic team in a fast-paced and innovative environment. If you are a self-starter with a passion for technology and a commitment to customer satisfaction, this is the job for you.

Job Title: Director of Clinical Quality

Location: Modesto, CA

Schedule: Monday–Friday (Director-level role with 24/7 departmental accountability)

Salary Range: $140,000 – $220,000 (DOE)

Relocation: Available based on candidate location and distance

Wheeler Staffing Partners is seeking an experienced Director of Clinical Quality to serve as a senior hospital leader responsible for quality outcomes, patient safety, regulatory compliance, and performance improvement initiatives. This executive-level role reports to the Chief Nursing Officer and is accountable for hospital-wide quality strategy and measurable clinical outcomes.

Position Summary

The Director of Clinical Quality provides strategic leadership for hospital-wide Quality Assessment and Performance Improvement (QAPI) programs. This role ensures delivery of safe, patient-centered, outcomes-based, and cost-effective care while maintaining compliance with accreditation and regulatory agencies.

The Director leads initiatives related to:

• Quality outcomes and performance improvement
• Patient safety programs
• Regulatory and accreditation compliance
• Peer review and risk management
• Infection prevention and control
• Clinical data analysis and reporting

This role requires strong executive presence, analytical expertise, and the ability to lead multidisciplinary teams in a complex hospital environment.

Key Responsibilities

• Develop, implement, and oversee hospital-wide quality and performance improvement programs
• Monitor clinical outcomes and identify opportunities for measurable improvement
• Lead patient safety initiatives and ensure appropriate incident reporting processes
• Ensure compliance with Joint Commission, CMS, state regulatory, and accreditation standards
• Oversee Infection Prevention, Risk Management, Peer Review, and related quality functions
• Analyze hospital data, dashboards, and quality metrics to drive strategic decisions
• Present quality performance reports to executive leadership and medical staff committees
• Lead regulatory survey readiness and accreditation preparation efforts
• Drive culture change initiatives to support high-reliability healthcare practices
• Coordinate multidisciplinary teams to achieve quality benchmarks and performance goals

Minimum Qualifications

Education

• Bachelor’s, Master’s, or Doctorate degree in a health-related field
• OR
• Extensive hospital-based quality leadership experience (7+ years) in quality or performance improvement

Required Experience

• Director or Assistant Director-level leadership experience
• Hospital-based Quality and Performance Improvement leadership
• Experience in:
• Outcomes management
• Peer review
• Risk management
• Patient safety
• Infection prevention
• Direct experience working with:
• The Joint Commission
• Centers for Medicare & Medicaid Services (CMS)
• State regulatory agencies

Required Skills & Competencies

• Strong analytical and statistical skills
• Advanced proficiency in Excel, databases, dashboards, and quality reporting tools
• Ability to interpret clinical and operational data
• Executive-level communication and presentation skills
• Proven ability to lead multidisciplinary teams
• Experience driving change in complex hospital environments
• Knowledge of Quality Improvement Organization (QIO) processes and current quality trends

Physical Requirements

• Prolonged standing and walking
• Ability to lift, position, or push up to 50 pounds
• Manual dexterity and mobility as required in hospital environments

Benefits Overview

Comprehensive benefits package may include:

• Medical, dental, vision, and prescription coverage
• Behavioral health and telemedicine services
• 401(k) with employer match
• Paid time off and leave programs
• Tuition assistance and certification support
• Student loan assistance programs
• Employee Assistance Program (EAP)
• Flexible spending accounts
• Supplemental insurance and financial wellness resources

Benefits eligibility may vary based on employment status and location.

If you are an experienced hospital quality leader with Director-level experience and a strong background in regulatory compliance, patient safety, and performance improvement, apply today to explore this leadership opportunity in Modesto, CA.*

Drive Excellence. Lead Change. Make an Impact.

CHEP, a global leader in sustainable supply chain solutions, is seeking a passionate Operations Quality & Continuous Improvement Supervisor to join our Temple, TX team.

In this pivotal role, you’ll lead quality initiatives, champion continuous improvement, and collaborate across departments to deliver exceptional customer outcomes. You’ll be hands-on in mentoring your team, optimizing plant performance, and ensuring compliance with global standards—all while contributing to a culture of safety and innovation.

Key Accountabilities - What you will do:

• Develops and drives continuous improvement initiatives to ensure that the quality control function meets key performance indicator goals.
• Supervise and coordinate the work of all quality department employees.
• Provide hands-on leadership as a supervisor; responsible for mentoring and coaching all quality employees and working through employee relations issues
• Drives compliance of CHEP quality guidelines at the service center.
• In partnership with Plant Manager, provide leadership to the quality staff to effectively recruit, train, develop, evaluate, motivate, delegate, and monitor their activities.
• Collaborates with plant leadership to ensure compliance to established policies.
• Ensure the consistent execution of all SOPs throughout the Plant in accordance with the QMS, PMS, Commercial Organization, and Global Supply Chain.
• Support cost control initiatives and process control within the Plant.
• Responsible, in consultation with Plant Manager, for the cost and yield performance of the Plan in partnership with the overall P&L of the Plant.
• Deliver best operational practices and cost efficiencies across the Plant while maintaining critical quality and raw material utilization standards that are necessary to maintain customer satisfaction and Plant profitability.
• Ensure compliance through teamwork for all Standard Operating Procedures within the Plant.
• Manages and ensures proper documentation of all quality related documents for all plant personnel.
• Develop, lead, organize group projects targeting quality systems and continuous process improvements. Reports on progress and project deliverables.
• Partners with Regional Quality personnel and the greater quality team to resolve concerns and execute on strategic goals of the organization.
• Collaborates with Plant HSE Supervisor and HSE Plant Lead to support and drive Safety improvements (Zero Harm) across the Plant.
• Conduct and lead Train the Trainer program for all training personnel as it relates to quality.

Qualifications

• Bachelor’s degree is preferred OR relevant business experience

Experience-What You will bring:

• 3-5 years’ experience in Quality Assurance or Continuous improvement specialized role.
• Lean Six Sigma certification(s) preferred
• Prior experience in a plant or quality supervisory role
• Strong customer focus orientation.
• Demonstrated ability to work in a challenging environment.
• Ability to lead a team.
• Ability to give and receive constructive feedback.
• Demonstrated ability to work cross-functionally.
• Understanding of supply chain practices and metrics.
• Knowledge of manufacturing operations, training quality and production employees.
• Knowledge and experience of quality control program implementation.
• Basic knowledge of OSHA standards.
• 3+ year’s line leadership experience.
• Demonstrated ability to communicate effectively with Director and above level leadership.

Skills and Knowledge

• Proven ability to get results through mentoring skills - effective coaching, facilitation & presentation
• Strong communication skills
• Excellent problem-solving skills and strategic thinking ability.
• Data analysis
• Critical thinking
• Organizational and time management skills
• Strong MS Office knowledge and skills including Excel, Word and PowerPoint
• Quality Mindset
• Coaching and delegation
• Conflict Management

Languages

• English - Required
• Spanish - Preferred

What we Offer:

• Competitive Pay
• Benefits Day 1!
• 401K w/ company match (up to 4%)
• FREE company-paid vision, short-term disability, and life insurance!!
• FREE company-provided PPE and safety equipment
• Tuition reimbursement, wellness incentives, parental leave, childcare assistance, profit sharing, and MORE!

Compensation Statement: The salary range for this position is $62,000 to $84,000 per year. Salary ranges provided take into account a wide variety of factors that are considered in making compensation decisions including but not limited to skill sets; experience and training; licensure and certifications, geographic differentials and other business and organizational needs. Therefore, actual amounts offered may be higher or lower than the range provided. If you have questions, please speak to your Talent Acquisition Partner about the flexibility and detail of our compensation philosophy.

Dependent on the position offered, other forms of compensation may be part of a total offering beyond medical & retirement benefits and may include other monetary incentives or business benefits.

Quality Engineer

As a Quality Engineer, you will assist with the development of quality systems, procedures and controls to ensure that all medical products consistently meet performance and quality specifications in the Germantown Manufacturing facility. The Quality Engineer is a leader and strong technical resource who quickly and effectively resolves quality problems with internal and external customers and suppliers.

Below Are Additional Duties And Responsibilities

• Generates, communicates, and implements ideas and solutions.
• Demonstrates accuracy and thoroughness in completing tasks timely.
• Looks for ways to improve and promote quality.
• Monitor Corrective Action System (i.e. Customer Complaints, Supplier, Internal)
• Initiate and investigate Customer Complaints according to our internal procedure and standards.
• Record essential information on internal and/or customer-specific documentation, including updating customer portals.
• Perform investigations using Lean, Six Sigma, and statistical methods to support root cause analysis and corrective actions.
• Identify gaps and/or trends in systems or processes.
• Initiate and facilitate the Corrective/Preventative Action process using the appropriate quality tools and input from subject matter experts (SME) to implement sustainable solutions.
• Update Quality documents according to our Change Control procedures, as required.
• Verify corrective action effectiveness.
• Drive Non-Conformance Process
• Evaluate and investigate suspect non-conforming product identified by manufacturing and/or the Quality Lab.
• Initiate containment activities, as necessary, with Customer Service and Shipping Department.
• Recommend disposition of product based on thorough investigation and data-driven feedback.
• Initiate and assist Customer Service with Return Material Authorization (RMA) process.
• Develop re-inspection, sort, and/or rework instructions for Manufacturing Operators, as required.
• Collaborate with customer on issuing waiver or deviation documentation and obtain customer approval, as required.
• Maintain the Quality Management System (QMS).
• Understand ISO 13485 Quality management systems requirements.
• Ensure continuing compliance to both internal processes as well as requirements imposed by certification bodies, regulatory agencies, and specific customer requirements.
• Assist in internal, 2nd party, and 3rd party audits.
• Assist with responses and corrective actions for audit findings.
• Support Product Realization process
• Participate in design review, process planning, and failure mode analysis
• Provide input on evaluation of Key Product Characteristics.
• Provide input on gaging methods and equipment.
• Interpret customer requirements including complex blueprints and GD&T call-outs.
• Review and approve Engineering Change Notifications and Verifications
• Evaluate for feasibility and implement updates to customer requirements into associated product control plans, pFMEA, Inspection documentation and other related documents.
• Incorporate industry standard best practices.
• Incorporate lessons learned.
• Evaluate, submit and track Supplier Change Notices to customers and/or suppliers.
• Any other duties as assigned.
• Manufacturing point of contact for the review and disposition of product quality related questions.
• Approve Medical Device release for shipment, as required.
• Perform batch record reviews for medical device prior to release for shipment.
• Generate Certificate of Analysis, as required.
• Release product in ERP system based on customer and process requirements.
• Support Manufacturing process
• Train Manufacturing and Quality Control personnel on customer requirements, inspection techniques, lessons learned, and rework instructions.
• Manage product inspection and testing activities.
• Obtain customer approvals for all required changes based on Quality Agreements.
• Compile supporting measurement and process performance data, as necessary
• Assemble supporting documentation package and review for completeness and accuracy
• Review and approve production documentation updates according to our Engineering Change Order process.

Founded in 1984, Best Formulations LLC, a diversified nutraceutical and personal care company headquartered in City of Industry, California, is a contract manufacturer of thousands of branded SKUs, including high quality nutritional supplements. At the core of our ethos is a dedication to personal care, where every product is crafted with meticulous attention to detail and the highest standards of quality. Our longstanding expertise in contract manufacturing dietary supplements has uniquely positioned us as leaders in research, regulatory compliance, and quality assurance.

About the role:

We are seeking an experienced Quality Executive to lead our Quality Compliance and Quality Control functions within a dynamic lab environment. This role is pivotal in ensuring that all products meet regulatory standards, customer expectations, and internal quality benchmarks. The ideal candidate will champion a Quality by Design approach, fostering a culture of continuous improvement and operational excellence.

How will you contribute:

Quality Compliance:

• Ensure adherence to all relevant regulatory requirements (FDA, GMP, ISO, etc.) for nutraceutical manufacturing.
• Maintain and update quality systems, SOPs, and documentation to meet compliance standards.
• Oversee audits (internal, external, and customer) and manage corrective/preventive actions.

Quality Control:

• Lead and manage QC operations, including raw material, in-process, and finished product testing.
• Ensure robust analytical and microbiological testing processes are in place and validated.
• Collaborate with R&D and production teams to resolve quality issues promptly.

Strategic Leadership:

• Develop and implement a Quality by Design framework across all processes.
• Drive continuous improvement initiatives to enhance product quality and operational efficiency.
• Build and mentor a high-performing quality team.

Minimum Requirements/Qualifications:

• Bachelor’s or master’s degree in quality assurance, Chemistry, Pharmaceutical Sciences, or related field.
• Minimum 8+ years of experience in Quality roles within nutraceutical, pharmaceutical, or food manufacturing industries.
• Previous experience in dietary supplements manufacturing, specifically with soft gel dosage forms, is highly preferred.
• Strong knowledge of regulatory requirements (FDA, GMP, ISO standards) and other regulatory frameworks relevant to nutraceutical manufacturing.
• Proven experience in managing audits and compliance programs.
• Familiarity with analytical and microbiological testing methods.
• Excellent communication, interpersonal, and organizational skills.
• Certifications preferred: ASQ Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), Preventive Controls Qualified Individual (PCQI) or other relevant quality or regulatory certifications.

Work Environment:

• May involve exposure to allergens such as Soy, Wheat, Fish, Shellfish, Milk, Egg, Tree Nuts and Sesame.

More about us:

As a valued strategic partner, Best Formulations offers a comprehensive program of services, turnkey solutions, and client support that is unmatched in the industry. Our product development team can provide customized, proprietary formulations designed specifically to meet the needs of our customers and their method of distribution. Our vertically integrated manufacturing and packaging process allows us to schedule flexible production runs to respond quickly to shifting market demands. Every step of the way, we are committed to your growth and success!

"To develop and strengthen mutually beneficial relationships with our employees, customers, and business partners by providing the highest quality products and the Best customer service. Together We Grow!"

EEO Statement

Best Formulations is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Best Formulations will work with applicants to meet accommodation needs that are made known to Best Formulations in advance.

Kelly is hiring for a Specialist - Quality Control for a 12-month contract role at Chesterfield, MO 63017 with our prestigious client.

Job Title: Specialist - Quality Control/ Quality Coordinator

Primary Location: 16401 Swingley Ridge Rd Ste 700, Chesterfield, MO 63017

12-month contract - Onsite role

Shift: 8:00 AM to 4:30 PM

Pay rate: $30-38.50/hr.

Summary: The Laird Chesterfield site is seeking a Quality Coordinator. Laird designs, develops and delivers industry leading solutions that protect electronics to enhance the performance and reliability for our customers. Our global organization of world-class scientists and engineers provide solutions to our existing and future customers’ complex problems. A successful candidate will lead the Chesterfield location’s Quality Management System requirements as well as key improvement programs, including support for automotive and aerospace manufacturing sites across Laird. This specific location is not a manufacturing site but includes processes and activities such as Sales, Quoting, Customer Service and some Product Design. Other activities related to quality include but are not limited to system implementation, standardization, and automation. The Quality Coordinator will ensure that the organization’s Quality Management System conforms to internal, Quality Standard requirements (ISO 9001 and others), customer requirements, and any applicable regulatory/legal requirements. The role will collaborate with site leadership, business leadership, and Laird Quality Leaders to ensure compliance and drive continual improvement of the Chesterfield QMS. This position will report to the Laird North America Quality Leader.

RESPONSIBILITIES

• Implementation, support, and improvement of the Quality Management System (QMS) for this site.

• Maintain site metrics and communicate with business and quality leaders on site quality performance; review recommend areas for focus and attention

• Support QMS interfaces with other Manufacturing sites; this location is a remote support location for other sites

• Maintain and improve conformance to applicable Quality Standard requirements including ISO 9001, IATF 16949, AS9100 etc.

• Coordination of and participation in QMS audits by 3rd party Certification Bodies (CB); act as liaison between site team and CB

• Coordinate, maintain and improve internal audit program in compliance with Quality Standards and any relevant customer specific requirements

• Coordinate Management Review activities for Chesterfield and support of other manufacturing sites

• Conduct training on QMS procedures as required and maintain associated records

• Improve and maintain documented information control activities, including revision of the Quality Manual, development of document reviews, and control of related records

• Lead Corrective Action activities; monitor completion of assigned investigations and corrective actions; conduct verification of effectiveness

• Lead investigations on internal and 3rd party NCs; improve and maintain employee competence in problem solving

• Coordinate and track continual improvement projects; evaluate effectiveness to customer or business goals/impact

• Analyze data and trends in support of QMS processes and other site activities such as customer service, customer satisfaction, complaints, or quoting

• Support the Document Change Management process for the Chesterfield site

• Additional administrative responsibilities and support for other functions at the site as needed

REQUIREMENTS

• Proficient knowledge of ISO 9001 (minimum), IATF 16949 and AS9100D desirable

• Good communication skills, both written and oral.

• Ability to maintain accuracy and attention to detail.

• Ability to work as an individual contributor or in a team environment.

• Experience performing Internal Audits

• Experience with CAPA systems

EDUCATION / EXPERIENCE

• Bachelor’s degree in a related field (Quality Mgmt., Operations, Manufacturing Mgmt., etc.)

• Minimum 7-10 years’ experience working within and/or managing a QMS certified to ISO 9001:2015 (IATF 169949 desired)

• Lead or Internal Auditor certification for ISO 9001:2015 and/or IATF 16949:2016 (desired)

• Ability to understand relevant industry controls and requirements in support of manufacturing support processes to achieve and maintain compliance with relevant Standards

• Leadership and project management skills to drive improvement projects

• Root Cause/Corrective Action training and experience

• Proficiency in Microsoft Office applications and any other relevant systems for the management of documents, corrective actions, projects, etc.

If you feel this role interests you, feel free to apply or refer someone who would be a good fit.

Job Title: Director of Quality Assurance – Tissue Processing

Location: San Antonio, Texas, USA

Department: Quality Assurance / Regulatory Affairs

Reports To: Executive Leadership

FLSA Status: Exempt

Position Summary

The Director of Quality Assurance is responsible for providing strategic leadership, direction, and oversight to the company’s Quality Management System (QMS) to ensure compliance with international and domestic tissue processing regulations, standards, and corporate policies. This role establishes quality strategy, directs organizational compliance programs, and ensures alignment with corporate objectives across all quality assurance processes, including regulatory compliance, internal and external audits, risk management, supplier quality, and continuous improvement initiatives. The Director of Quality Assurance serves as a key member of the leadership team, providing executive-level guidance on quality strategy and regulatory risk management, ensuring the delivery of safe and effective products that meet or exceed customer and regulatory requirements.

Essential Duties and Responsibilities

• Lead the implementation, maintenance, and improvement of the QMS in compliance with cGMPs, ISO 13485:2016, ISO 14971:2019, and FDA 21 CFR:

Part 11 (Electronic Records; Electronic Signatures), 

Part 820 (QSR)

Parts 361/1271 (Human Cells, Tissues, and Cellular and Tissue-Based Products)

And the relevant FDA Guidance documents for these regulations

• Provide oversight of product release strategy and ensure compliance through delegated authority.
• Establish and oversee policies for raw material acceptance, supplier controls, and product disposition.
• Ensure organizational compliance with labeling and packaging requirements through policy, audit, and review.
• Plan, manage, and resource internal audits, supplier audits, and regulatory inspections; serve as the host and primary point of contact for regulatory and notified body representatives.
• Assure programs related to document control, GMP training program, and controlled record management are in compliance.
• Direct Quality approval for the CAPA process, including nonconformance handling, root cause analysis, corrective/preventive action planning, and effectiveness verification.
• Provide oversight and guidance for product risk management in accordance with ISO 14971.  Perform the quality review function for device pFMEA/dFMEAs and design control through delegation to appropriately trained and qualified staff.
• Review and approve quality-related documentation, including validation protocols, verification reports, design control deliverables, and batch records.
• Develop the key quality metrics for the periodic QMSR (Quality Management Systems Review) to drive systemic improvements, enhancing compliance and operational effectiveness.  
• Develop, mentor, and direct the Quality team and oversee staff development across multiple quality functions to ensure alignment with company goals and regulatory expectations.
• Partner with cross-functional teams (Process Engineering, Manufacturing, Warehouse/Distribution, Regulatory Affairs, Operations, Sales) to support quality throughout the product lifecycle.
• Competency and proficiency in making standard Regulatory submissions, updates, and communications, such as FDA Establishment Registrations, 510k’s, State Registrations, and FSCA for Medical Devices. 
• Ability to guide the organization to compliantly launch new medical device products and configurations to market

Required Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Quality, or related field; advanced degree strongly preferred.
•  Minimum of 10–12 years of progressive experience in tissue processing quality assurance, with at least 5+ years in a director-level or equivalent leadership capacity.
• Comprehensive knowledge of ISO 13485, FDA 21 CFR Part 820, ISO 14971, and EU MDR.
• Demonstrated experience and favorable outcomes with FDA inspections, notified body audits, and supplier quality programs.
• Expertise in QMS software platforms and document control systems.
• Strong analytical, problem-solving, and decision-making skills. 
• Professional certifications CQA, CQE, LSSBB, or RAC.

Competencies

• Executive leadership and organizational management skills
• Regulatory compliance expertise
• Effective communication and presentation abilities, including executive reporting and Board-level communication
• Strong attention to detail
• Continuous improvement mindset
• Demonstrated ability to mentor and coach staff and peers

Work Environment & Physical Requirements

• This position operates in a professional office and/or manufacturing environment.
• Regular use of computers, phones, and office equipment.
• May require occasional lifting of materials up to 25 pounds.
• Exposure to manufacturing floor environments.

Travel Requirements

• Occasional domestic travel may be required (estimated 20%) to support audits, supplier evaluations, and regulatory inspections.

Compensation & Benefits

• Competitive base salary commensurate with experience.
• Performance-based annual bonus eligibility.
• Comprehensive benefits package, including medical, dental, vision, life insurance, and 401(k) with company match.
• Paid time off, sick leave, and company holidays.
• Professional development opportunities and continuing education support.

Our client is seeking an experienced Plant Quality Manager to oversee and manage the quality assurance processes at their automotive manufacturing facility. The successful candidate will lead a team of quality engineers, technicians and coordinators ensuring the highest standards of quality are maintained throughout the production process. This role is critical in driving continuous improvement initiatives and maintaining compliance with industry standards and customer requirements. FULL RELOCATION ASSISTANCE IS AVAILABLE!

Key Responsibilities:

- Lead and manage the plant quality department, including a team of quality engineers, to ensure quality objectives are met.

- Develop, implement, and maintain quality assurance systems and processes to ensure product quality and compliance with industry standards and customer specifications.

- Collaborate with cross-functional teams, including production, engineering, and supply chain, to identify and resolve quality issues.

- Drive continuous improvement initiatives to enhance product quality, reduce defects, and optimize manufacturing processes.

- Monitor and analyze quality performance metrics, preparing reports and presenting findings to senior management.

- Oversee the auditing process of internal systems and processes to ensure compliance with ISO standards and other relevant regulations.

- Manage customer quality concerns and lead problem-solving efforts to address and resolve issues promptly.

- Develop and maintain strong relationships with key customers and suppliers to ensure quality expectations are met and exceeded.

- Train and mentor quality engineers and production staff on quality standards, procedures, and best practices.

- Stay updated on industry trends, advancements, and regulatory changes to ensure ongoing compliance and competitiveness.

What we are seeking:

- Bachelor’s degree in Engineering, Quality Management, or a related field. Advanced degree preferred.

- Proven experience in quality management within the automotive industry preferred.

- Strong leadership skills with a track record of effectively leading and developing a team of quality engineers.

- In-depth knowledge of quality management systems, ISO standards, and automotive industry standards (e.g., IATF 16949).

- Excellent problem-solving and analytical skills with the ability to drive root cause analysis and corrective actions. (PPAP, PFEMA, etc)

- Strong communication and interpersonal skills, with the ability to collaborate effectively across all levels of the organization.

- Proficient in quality management software and tools.

- Certification in quality management (e.g., Six Sigma, ASQ CQE) is a plus.

Erlanger, KY

Travel:5-10%

Reports to: CEO

Steuart Nutrition exists to glorify God by creating life-giving products.

We believe culture and character drive results. Our focus is to build long-term partnerships, operate with integrity, and manufacture high-quality supplement products for growing brands.

Steuart Nutrition is a supplement manufacturing company based in Erlanger, Kentucky. We are scaling our operations through robotics, AI-driven workflows, and process automation to build a highly efficient, forward-thinking manufacturing platform. We take a proactive approach to business development through product development and operationalizing supply chain partnership.

We work with brands across the supplement, wellness, and sports nutrition industries and are focused on long-term growth and operational excellence.

We are hiring a Quality Site Manager to lead and build the quality program for our Erlanger, Kentucky manufacturing facility.

This role will oversee site quality systems, laboratory operations, and cross-functional quality initiatives while working closely with Operations, Production, and Leadership teams. The Quality Site Manager will be responsible for ensuring our manufacturing processes consistently meet high standards for safety, compliance, and product integrity.

This role requires a hands-on leader with strong problem-solving skills and a systems mindset. You will help design and implement modern quality systems that improve accuracy, accountability, and continuous improvement across the facility as we scale our operations.

Lead and manage the site-wide quality program including sanitation, allergen control, ingredient verification, seal integrity, and traceability

Develop and oversee digital quality workflows, metrics, and reporting systems

Establish and manage an internal testing lab, including equipment, systems, and team development

Monitor production quality performance and implement improvements when issues arise

Partner with Operations, Production, and Engineering teams to integrate quality into daily processes

Ensure audit readiness, regulatory compliance, and strong documentation practices

Implement root-cause analysis and corrective actions to prevent recurring issues

Develop dashboards, KPIs, and reporting tools that track quality performance

Coach cross-functional teams to strengthen ownership and accountability for quality outcomes

Represent Steuart Nutrition’s mission and culture through high standards of integrity and leadership

Strong leadership and problem-solving skills with a systems-oriented mindset

Ability to build and improve quality processes in a manufacturing environment

Strong communication skills and ability to collaborate across departments

Hands-on approach to troubleshooting and process improvement

Organized, detail-oriented, and comfortable managing multiple priorities

Alignment with our mission, values, and a character-driven workplace

Experience in quality management, manufacturing, or food/supplement production preferred

Experience with audits, root-cause analysis, metrics, or quality systems is strongly preferred

Microbiology lab experience, aseptic sampling methods, or GLP experience are helpful but not required

Interest in automation, digital tools, or data-driven quality systems is a plus

No degree required — capability, discipline, and character matter most.

Compensation is benchmarked to Quality Management roles in Northern Kentucky and the Greater Cincinnati manufacturing market.

As Steuart Nutrition continues to scale, this leadership role may expand into broader quality or operational leadership across the organization.

Potential future paths include Multi-Site Quality Leadership, Corporate Quality Roles, or hybrid leadership opportunities across Quality and R&D depending on performance and company growth.

Hi, thank you for applying for this position. In a paragraph of at least 6 sentences, please answer the following questions:

1. What about our mission + values excites you? And why?
2. Describe the team environment where you do your best work.
3. When you miss a goal, what do you usually attribute it to?
4. 
   
5. Tell me about a time something went wrong at work that wasn’t your fault. What did you do next?

Composition Brands is an independent residential kitchen and outdoor living company with a portfolio of premium and ultra-luxury brands including Viking, AGA, Rangemaster, La Cornue, Lynx, and U-Line. With operations across North America and Europe, the company is focused on long-term brand stewardship, thoughtful design, and scalable growth. To learn more, visit Summary:

The Group Quality Manager leads the end-to-end global quality strategy across all appliance platforms, manufacturing sites, suppliers, and contract manufacturing partners. This role ensures product safety, regulatory compliance, reliability, and a consistent premium customer experience while reducing warranty costs and protecting brand reputation in high-volume, long-life products.

Serving as the global leader for appliance quality strategy, this position oversees mechanical, electrical, electronic, thermal, and software-related quality throughout the full product lifecycle - from concept development through field performance - across refrigeration, cooking, ventilation, and dishwashing product categories.

This role reports directly to the President and is based in the Atlanta, GA area, with approximately 30–50% travel to domestic and international manufacturing sites, suppliers, and contract manufacturing partners.

Responsibilities:

Quality Strategy & Governance

• Define and deploy a global quality strategy for major appliances aligned with brand, safety, cost, and reliability objectives.
• Establish standardized quality policies, procedures, and KPIs across all regions and platforms.
• Act as executive escalation owner for product safety incidents, regulatory actions, recalls, and field campaigns.
• Lead management reviews and risk assessments at executive level.

Quality Management Systems & Regulatory Compliance

• Own and govern the group QMS aligned appliance-specific requirements.
• Ensure compliance with UL, CSA, IEC, CE, NOM, DOE energy efficiency, EPA refrigerant regulations, and regional safety standards.
• Lead internal, external, customer, and certification audits, as needed.
• Ensure effective CAPA systems and sustained corrective actions.

Product Development & Design Quality

• Partner with R&D to embed design-for-quality, design-for-reliability, and design-for-compliance.
• Govern DFMEA, DVP&R, reliability testing, HALT/HASS, and validation plans.
• Ensure robust design transfer and quality gates from concept through SOP.
• Approve product and engineering changes impacting safety, performance, or compliance.

Manufacturing & Process Quality

• Standardize quality processes across major appliance assembly lines, including:
• Critical-to-safety and critical-to-quality characteristics
• SPC and process capability for key operations
• Functional, safety, and end-of-line testing
• Drive defect prevention through error-proofing, in-line controls, and layered process audits.
• Support new factory launches, line transfers, and capacity expansions.

Supplier & Component Quality

• Define supplier quality standards for critical major appliance components including compressors, sealed systems, gas components, heaters, motors, PCBs, wiring harnesses, insulation, coatings, and structural parts.
• Oversee supplier qualification, audits, and ongoing performance.
• Partner with Sourcing to mitigate supply risk and manage supplier change control.
• Lead resolution of high-risk supplier quality issues.

Customer Quality, Field Performance & Warranty

• Own customer quality metrics including warranty claims, field failures, service call rates, and repeat repairs.
• Partner with Service, Field Operations, and Retail partners to analyze failure trends.
• Lead structured root cause analysis and corrective actions for systemic issues.
• Drive continuous reduction of warranty cost and field campaigns.

Cost of Poor Quality & Continuous Improvement

• Establish and manage Cost of Poor Quality (COPQ) across plants and suppliers.
• Lead cross-functional initiatives to reduce scrap, rework, returns, and warranty expense.
• Deploy Lean Six Sigma and reliability engineering methodologies.

Requirements:

• Bachelor’s degree in Engineering (Mechanical, Electrical, Industrial, or related)
• 12+ years of quality leadership in major appliance or durable consumer goods manufacturing
• Strong knowledge of regulations and certification processes
• Proven success reducing warranty and field failure costs.
• Ability to lead global, cross-functional teams.
• Proven ability to influence, manage teams, and deliver change.
• New product development and release readiness experience.
• Six Sigma Black Belt or equivalent preferred.
• Experience leading recalls, field campaigns, or regulatory investigations preferred.
• Experience in global manufacturing and sourcing environments preferred.
• Experience in lean transformation and development of engaged workforce culture preferred.
• Reliability testing experience preferred.
• Experience in sheet metal fabrication, paint, welding, final assembly preferred.

Composition Brands is an Equal Employment Opportunity (EOE/M/F/Vets/Disabled) employer and welcomes all qualified applicants.

Long-Term Contract Role in Orangeville, UT!

Job Summary

The Quality Control Representative is responsible for implementing and enforcing the project’s Quality Plan to ensure compliance with contract requirements, industry standards, and company policies. This role oversees inspections, testing activities, and quality documentation while coordinating with third-party inspectors, project teams, and suppliers to ensure all work meets required specifications. The position also supports risk identification, maintains audit-ready records, and promotes a strong culture of quality, safety, and accountability across the project.

Job Description

• Enforce the Project Quality Plan to ensure consistent implementation across the project.
• Executing project quality policies and procedures
• Coordinate independent inspection contractor activities and schedules so crews are never waiting on quality sign offs.
• Oversees verification inspections for high-risk activities and ensures acceptance criteria are met.
• Ensures all inspection reports, test results, NCRs, corrective actions, and quality records are complete, accurate, and audit ready.
• Reviews and approve inspection/test results for compliance with contract documents, specifications, codes, and standards
• Communicates proactively with project leadership, third party inspectors, and design partners to address concerns before they escalate.
• Reviews supplier quality documentation for contract compliance
• Identifies quality related risks early and work with project leadership to mitigate them
• Guides junior quality specialists and field engineers on quality processes, documentation, and technical requirements.
• Reinforces expectations for a strong quality culture on the project, reinforcing standards for safety, quality, workmanship, and accountability.
• Be detail oriented and able to multitask
• Provide reports to project management and clients as requested.

Skills Required

• Must have experience managing documentation for the project
• Experience scheduling and overseeing 3rd party testing, developing inspection reports, and corrective actions and ensuring materials and equipment meet company standards and specifications.
• Expert knowledge of construction industry codes and Standards such as ACI and ICC.
• Highly motivated with a demonstrated passion for excellence
• Excellent attention to detail and organizational skills
• Ability to multi-task, problem solve, work collaboratively, and be a solution provider.
• Strong communication (verbal and written) and interpersonal skills
• Reliable and punctual.
• Perform work safely and effectively.
• Work overtime and weekend as needed

Education/Training/Certifications

• High School Degree or GED
• Bachelor’s degree in Civil Engineering, Construction Management, or a related field is a plus

*GAS Global Services LLC is an Equal Opportunity Employer. Employment Decision are made without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity or any other factors protected by applicable federal, state or local laws.

JOB-10046129

Title : API EM Quality Assurance Associate

Location : Indianapolis, IN

Duration – 12 months

Key Objectives/Deliverables:

• Serve as a liaison between CMs and Client.

• Provide quality oversight of Quality control activities at CMs including being the initial point of contact for all quality-related issues with testing.

• Provide quality oversight of CM method validation or method transfer activities

• Escalate quality issues at CMs to Client QA management.

• Assist in the establishment and revisions of Quality Agreements with affiliates and customers.

• Ensure compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs).

• Coordinate and perform quality responsibilities of API shipments for stability testing. Provide quality oversight of API EM stability program.

• Participate in regulatory inspection preparations with CMs.

• Ensure that documented checks have been completed for the Certificates of Testing and Certificates of Environmental Monitoring (where applicable), and deviations, changes and batch documentation that demonstrates requirements have been met prior to batch release.

• Provide quality support of Quality Control with the focus on holistic review of key activities associated with or impacting the quality control testing including deviations, change controls and countermeasures.

• Assess the impact of analytical deviation investigations and changes and ensure that all appropriate records are documented and retrievable.

• Maintain awareness of external regulatory agency findings which individually or collectively reference the quality of the product.

• Review and approve documents including, but not limited to, analytical procedures, change control proposals, deviations, analytical equipment qualifications, analytical methods and computerized system validations.

• Participate in APR activities.

• Participate in projects to improve productivity.

• Participate in Joint Process (JPT) and Post Launch Optimization (PLOT) Teams.

Quals--

• At Client, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
• Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization (API-EM) that delivers a diverse portfolio of medicines essential to our patients around the world. The API EM Quality Assurance for Quality Control provides support to all QC activities at Contract Manufacturing organizations (CMs).
• The QA for QC position is essential for ensuring that all QC testing is in accordance with the validated methods and are compliant to cGMPs and regulatory commitments.

Basic Requirements:

• BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences.

• 5+ years of GMP Quality Control Laboratory knowledge and/or experience in API or finished product manufacturing, QA or Engineering.

Additional Preferences:

• Testing experience with Small Molecule
• Thorough technical understanding of quality systems and regulatory requirements relating to quality control laboratories
• Knowledge of pharmaceutical manufacturing operations.
• Demonstrated coaching and mentoring skills.
• Experience in root cause analysis.
• Demonstrated application of statistical skills.
• Demonstrated strong written and verbal communications skills.
• Strong attention to detail.
• Proficiency with computer system applications.
• Excellent interpersonal skills and networking skills.
• Ability to organize and prioritize multiple tasks.
• Ability to influence diverse groups and manage relationships.

Education Requirements:

• BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences.

Other Information:

• Must complete required training for API EM Quality Assurance.
• No certifications required.
• Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE.
• Must be able to support 24 hour/day operations.
• Up to 20% travel US & OUS.

Job Summary:

We are seeking a Supplier Quality Engineer (SQE) to manage and improve the quality of products supplied to our company. The ideal candidate will work closely with suppliers to ensure that their processes and products meet our quality standards and support continuous improvement initiatives. The SQE will also play a key role in supplier audits, problem-solving, and ensuring compliance with regulations and specifications.

Key Responsibilities:

• Supplier Audits and Assessment: Evaluate and qualify new suppliers by conducting audits, assessing their quality systems, and verifying compliance with standards. Regularly conduct on-site audits of existing and potential suppliers to ensure that their production processes and quality management systems (QMS) meet standards.
• Supplier Performance Monitoring: Track and analyze supplier performance, identify trends, and develop action plans to address quality issues.
• Root Cause Analysis: Work with suppliers to perform root cause analysis for defects or non-conforming materials and ensure implementation of corrective and preventive actions.
• Quality anomaly handling: When defects occur in incoming materials, we are responsible for issuing a SCAR (Supplier Corrective Action Report) and urging the supplier to find the root cause and implement preventive measures.
• Supplier coaching and development: Assist suppliers in improving their processes and implementing quality tools (such as SPC, 6 Sigma, FMEA) to increase yield and reduce costs.
• Collaboration with Internal Teams: Coordinate with procurement, engineering, and production teams to ensure supplier quality aligns with company requirements and standards.
• Documentation and Reporting: Maintain detailed records of supplier performance, audits, corrective actions, and quality documentation.
• Regulatory Compliance: Ensure supplier materials and processes comply with relevant industry standards and regulatory requirements.

Qualifications:

• Bachelor’s degree in engineering, Quality Management, or a related field.
• Minimum of 5 years of experience in supplier quality, quality assurance, or a related role in manufacturing.
• Knowledge of quality systems, standards (e.g., ISO 9001, Six Sigma), and best practices.
• Strong analytical, problem-solving, and communication skills.
• Experience with root cause analysis, corrective action processes, and quality improvement tools (e.g., FMEA, SPC, Control Plans).
• Ability to travel as required to visit suppliers.