Quality Custom Distribution Jobs in Usa

Job Summary

Shift: Every Other Wednesday and Every Thursday, Friday & Saturday 6am-6pm

• Develop, implement, and maintain quality control plans and procedures for new and existing products.

• Conduct root cause analysis for product non-conformances and process deviations, implementing effective corrective and preventive actions (CAPA).

• Perform statistical analysis of quality data to identify trends, opportunities for improvement, and risks.

• Participate in design reviews, process validations, and manufacturing readiness reviews to ensure quality requirements are met.

• Collaborate with cross-functional teams (e.g., R&D, Manufacturing, Supply Chain) to integrate quality into product development and production.

• Support internal and external audits, ensuring compliance with ISO standards, customer specifications, and regulatory requirements.

• Develop and deliver quality training to manufacturing personnel and other stakeholders.

• Review and approve engineering changes, ensuring their impact on product quality is assessed and controlled.

• Drive continuous improvement initiatives using methodologies such as Six Sigma, Lean Manufacturing, and FMEA.

• Document and report on key quality metrics and performance indicators.

Job Qualifications

• Bachelor's degree in Engineering (e.g., Mechanical, Electrical, Industrial, Manufacturing) or a related technical field.

• 3-5 years of experience in a Quality Engineering role within a manufacturing environment.

• Strong understanding of quality management systems (e.g., ISO 9001, AS9100, ISO 13485 depending on industry).

• Proficiency in statistical process control (SPC), measurement system analysis (MSA), and other quality tools.

• Demonstrated experience with root cause analysis methodologies (e.g., 8D, 5 Why, Fishbone diagrams).

• Excellent analytical, problem-solving, and decision-making skills.

• Strong communication and interpersonal skills, with the ability to effectively collaborate with diverse teams.

• Ability to read and interpret technical drawings and specifications.

• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).

• ASQ certifications (e.g., CQE, CSSBB) are a plus.

Quality Manger

LIGHT Helmets (Safer Sports, Inc.)

Carlsbad, CA (with occasional travel to supplier)

LIGHT Helmets is a cutting-edge football helmet manufacturer located in Carlsbad.  We are hiring immediately for a Production Manager for our assembly operations. We are a high growth company that offers career advancement opportunities.

LIGHT is looking for a HIGHLY MOTIVATED, FOCUSED individual to be part of our fun sports-oriented team. The ideal candidate must have excellent multi-tasking skills and perform a wide variety of duties including: 

·       Required Experience

• Minimum 2 years of experience managing Quality Assurance/Quality Control (QA/QC)
• ISO 9001 certification preferred
• Key Responsibilities 

o        Quality Oversight

• Manage all quality-related aspects of our products
• Oversee lot acceptance and inventory management
• Develop inspection standard operating procedures (SOPs) and acceptance criteria
• Monitor and ensure paint quality standards

o        Vendor and Product Compliance

• Manage vendor quality control procedures
• Ensure product compliance with internal and external standards

o        Quality System Management

• Oversee internal quality systems
• Maintain and update the quality management system to ensure compliance with the SEI Program Manual
• Lead SEI audit preparations and communications with the auditor

o        Product Testing

• Coordinate NOCSAE testing (initial and annual)
• Schedule testing and collaborate with production to build helmets for quality testing
• Manage in-house lab testing of products
• Perform routine maintenance and calibration of lab equipment
• Train lab technicians on helmet and component testing procedures
• Archive and manage testing data

o        Training and Documentation

• Train staff on quality inspection protocols
• Ensure ongoing compliance through regular training
• Handle documentation and reporting related to quality processes
• Compensation
• Base Salary $78,500-98,500
• Employee Stock Ownership plan after 12 months of contiguous employment
• Target Bonus 5-10% of base tied to predetermined KPIs related to defect, costs, etc.

My client is part of a larger company who is a key global player in the fermentation of microorganisms (yeasts and bacteria) for baking, taste, healthcare, and industrial biotechnology.

What you bring to the table

Wanting the opportunity to step into a key leadership position where your impact will be visible daily by having the autonomy to shape culture, modernize programs, and drive continuous improvement in quality, safety and sustainability performance—all while supporting a world-class fermentation company.

The ability to lead a team of 6 technicians in our QC and QA department while fostering a culture of excellence and ensuring that quality and safety are integrated into day-to-day operations and long-term strategies. While also being accountable for ensuring that the company's products and services meet the required quality standards.

Possessing the competency and having the responsibility of managing and monitoring company safety programs, policies and procedures that meet OHSA guidelines by planning, implementing and overseeing the Company's employee safety programs.

A few responsibilities you will have as the Quality and EHS Manager

• Development and implementation of quality standards, quality control plans, management systems, and policies and procedures

• Maintain the quality management system to ensure continuous improvement, including developing supporting standards and procedures and maintaining all related documentation

• Monitor and manage traceability of raw material quality and finished goods

• Responsible for updating facilities, policies, systems, and documentation to meet regulations set by federal, state, and local authorities, as well as all applicable certifying bodies

• Represent the company to external stakeholders such as certifiers, customers, and authorities while maintaining relationships with relevant external partnerships related to workplace health, safety, and environment

• Implement and renew the certifications required by customers and authorities

• Provide leadership for developing and directing quality assurance, inspection, laboratory, and quality improvement by scheduling and recording regular internal audits

• Promote company-wide quality awareness and compliance

• Manage the review and approval of complaints, non-conformances, and recommend corrective and preventative actions; lead root cause analysis and corrective action of nonconforming products (internally and externally)

• Ensure effective management of customer escalations, and timely and effective communication and resolution of issues that help drive customer satisfaction

• Ensure quality of finished goods based on legal and certification regulations, as well as customer needs

• Conduct and record environmental analyses, storage suitability, and other controls and analyses specified in the quality control plan during certain stages of production, storage, and shipment operations; provide information and guidance to relevant departments regarding the results of these analyses

• Manage and monitor safety KPIs for employee health and safety

• Implement safety training programs and initiatives for workplace safety

• Conduct risk assessments and implement preventative measures, ensuring they are followed daily

• Maintain documentation of the company's safety procedures, accidents, and related events

• Develop, manage, and maintain QHSE-related items at all levels (emergency evacuation to corporate initiatives)

• Develop an annual business plan to ensure the HSE management system meets business and legislated requirements

To succeed you must have

• Master of Science or bachelor's in microbiology, biotechnology, Quality management, Food science or a relevant degree program or a degree in an EHS related field of study.

• Multiple years of Health, Safety and Environment experience required, manufacturing experience preferred.

• Extensive experience in quality control operations in a Food, Biotech, high-tech industries, probiotics or Feed manufacturing industry is required

• Working knowledge of safety and environmental codes, OSHA, EPA regulations, and other regulatory agencies (Lockout-Tagout, Electrical Safety, Ergonomics, Air Quality and Emissions, Energy Management, etc.).

• Experience with behavior-based safety preferred (DuPont STOP).

• Background and expertise in HSE recordkeeping, reporting and compliance.

• Ability to work well under pressure, effectively handle conflict and demonstrate flexibility in work style to accommodate changing priorities and fixed deadlines.

• Experience and working knowledge of U.S. and Pennsylvania occupational health, safety and environmental regulations is preferred.

Description

Ready for more than just a job? Build a career with purpose.

At Lactalis in the USA, we're committed to providing meaningful opportunities for our people to learn, grow, and thrive-whether you're just starting your journey with us or looking to take the next step in your career. From day one, we offer the tools and support to help you succeed.

As the world leader in dairy, Lactalis is a family-owned company with over 85,000 pragmatic and ambitious professionals across the globe. Each day, we're proud to produce award-winning dairy products that bring people together.

In the US, we proudly offer an unrivaled house of beloved brands, including Galbani Italian cheeses and ricotta, President specialty cheeses and butters, Kraft natural and grated cheeses, Breakstone's cottage cheese, Cracker Barrel, Black Diamond cheddar, and Parmalat milk. Our yogurt portfolio includes siggi's, Stonyfield Organic, Brown Cow, Oui, Yoplait, Go-Gurt, :ratio, Green Mountain Creamery, and Mountain High, along with a growing family of ethnic favorites like Karoun, Gopi, and Arz.

At Lactalis, we live by our core values-Ambition, Engagement, and Simplicity. We foster a workplace where innovation thrives, diverse perspectives are celebrated, and everyone's unique background and ideas are valued.

Even if you don't meet every qualification, we encourage you to apply. We want to hear about your PASSION, your STORY, and how your EXPERTISE can help us shape the future

From your PASSION to ours

Lactalis U.S Yogurt, part of the Lactalis family of companies, is currently hiring a Quality Assurance Lab Supervisor in Casa Grande, AZ.

The Quality Assurance Lab Supervisor plays a crucial role in ensuring the safety, quality, and compliance of dairy products within our yogurt manufacturing facility. This position involves overseeing the overnight operations of the quality assurance laboratory, managing a team of lab technicians and facility custodians, and implementing quality control processes to meet regulatory standards and customer requirements.

From your EXPERTISE to ours

Key responsibilities for this position include:

• Lead and supervise a team of lab technicians and custodians, providing guidance, training, and performance feedback.
• Ensure adherence to safety protocols and laboratory procedures.
• Develop and implement quality control procedures for raw materials, in-process samples, and finished products.
• Conduct regular inspections and testing to verify product specifications and standards.
• Investigate and resolve quality issues, implementing corrective actions as necessary.
• Stay updated on relevant food safety regulations and industry standards.
• Ensure compliance with FDA, USDA, and other regulatory requirements.
• Maintain accurate records and documentation to support regulatory audits.
• Manage inventory of laboratory supplies and equipment, ensuring adequate stock levels and while working within the department's inventory budget.
• Calibrate and maintain laboratory equipment to ensure accuracy and reliability.
• Coordinate with other departments to prioritize testing needs and support production schedules.
• Identify opportunities for process improvement and efficiency gains in quality control procedures.
• Collaborate with cross-functional teams to implement best practices and quality enhancements.
• Participate in root cause analysis and corrective action planning for quality incidents.
• Provide ongoing training to lab staff on quality assurance protocols, testing methods, and safety procedures.
• Foster a culture of quality and accountability within the laboratory team.
• Perform other duties as assigned.

Requirements

From your STORY to ours

Qualified applicants will contribute the following:

Education & Experience

• Bachelor's degree in food science, microbiology, chemistry, or related field. Master's degree preferred.
• Certification in food safety (e.g., SQF, HACCP) a plus.
• Previous experience in a quality assurance role within the diary manufacturing industry.

Skills / Abilities / Knowledge

• Strong understanding of food safety regulations and HACCP principles.
• Proficiency in laboratory testing methods and instrumentation.
• Excellent leadership and communication skills.
• Detailed-oriented with a commitment to accuracy and precision.
• Ability to work collaboratively in a fast-paced production environment.
• Proficient in Microsoft Office Suite and Quality Management Systems.
• Regularly lift 10 lbs. Occasionally lift and/or move up to 50 lbs.
• Full range of body motion.
• Close vision.
• Sensory evaluations.
• Manufacturing environment with regular exposure to moving mechanical equipment.

At Lactalis, we offer a comprehensive Total Rewards Program with a variety of affordable benefits and coverage options. We support insurance costs significantly, contribute generously to retirement plans, and offer Paid Time Off from day one. We are committed to your professional growth, providing training and development opportunities, including Education Reimbursement. Join us and grow your career.

Lactalis is an equal employment opportunity employer. We will not discriminate against applicants with regard to any legally-recognized basis including, but not limited to: veteran status, race, color, religion, sex, national origin, age, marital status, sexual orientation, and physical or mental disabilities. Further, any division of the Company that is an Affirmative Action Employer will comply with all related legal obligations.

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.

Job Overview

The Sr. Engineer, Quality Operations is responsible for understanding quality requirements, developing and improving processes to meet those requirements, driving internal efforts for root cause analysis and corrective actions, while providing day to day support of processes to meet our high standards of precision and quality in producing medical devices.

Job Responsibilities and Essential Duties

In this role you will be responsible for developing and maintaining quality engineering methodologies and providing quality engineering support to production.

• 
  
• Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
  
• Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements
  
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving critical quality issues
  
• Lead process control and monitoring of CTQ parameters and specifications
  
• Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
  
• Lead the investigation, resolution and prevention of product and process non-conformances and related CAPAs
  
• Lead in the completion and maintenance of risk analysis
  

Minimum Requirements

• 
  
• Bachelor's Degree in Engineering or Science, or equivalent work experience.
  
• A minimum of 5-6 years of Quality Management Systems (QMS) experience.
  

Required Knowledge, Skills and Abilities

• 
  
• Good analytical and problem-solving skills.
  
• High level of attention to detail and accuracy.
  
• Strong computer skills, including MS Office applications and statistical software are required.
  
• Knowledge of Quality Assurance methods, such as process validation, design of experiments, statistical process control (SPC) and protocol/report preparation.
  
• Knowledge of ISO 13485 and FDA requirements
  

Supervision/ManagementOfOthers:

• 
  
• Sr. Engineer, Quality Operations will help to mentor more junior engineers.
  

Internal and External Contacts/Relationships

• 
  
• Sr. Engineer, Quality Operations position works closely with Operations, Manufacturing Engineering, Maintenance, Quality Compliance, Supplier Quality, and Continuous Improvement.
  

Environmental/Safety/Physical Work Conditions

• 
  
• Ensures environmental consciousness and safe practices are exhibited in decisions.
  
• Use of computer and telephone equipment and other related office accessories/devices to complete assignments.
  
• Office or production environment
  
• May work extended hours during peak business cycles.
  

The physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

$95K-120K with 10% STIP

#LI-YA2 #LI-Onsite

About us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Benefits at Getinge:

At Getinge, we offer a comprehensive benefits package, which includes:

• 
  
• Health, Dental, and Vision insurance benefits
  
• 401k plan with company match
  
• Paid Time Off
  
• Wellness initiative & Health Assistance Resources
  
• Life Insurance
  
• Short and Long Term Disability Benefits
  
• Health and Dependent Care Flexible Spending Accounts
  
• Commuter Benefits
  
• Parental and Caregiver Leave
  
• Tuition Reimbursement
  

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

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.

Job Overview

The Quality Engineer I Quality Operations specializes in Quality Operations, and is responsible for overseeing and improving the quality of manufacturing processes, ensuring compliance with regulatory requirements, and driving continuous improvement initiatives to enhance product quality and customer satisfaction. You will play a key role in ensuring that our manufacturing operations meet the highest standards of quality and efficiency while adhering to relevant regulations and industry best practices.

Job Responsibilities and Essential Duties

• 
  
• Develop, implement, and maintain quality control processes and procedures for manufacturing operations to ensure compliance with regulatory requirements and industry standards.
  
• Establish and monitor key performance indicators (KPIs) to assess manufacturing quality and identify opportunities for improvement.
  
• Participate/ Lead validation and verification activities for manufacturing processes, equipment, and software systems to ensure they meet quality and regulatory requirements.
  
• Develop/ review validation protocols, execute validation studies, and analyze data to ensure process robustness and reliability.
  
• Ensures through Design Transfer activities the Device Master Records (DMRs) contents are developed, controlled, and maintained leading to Risk based Manufacturing Control Plans.
  
• Support/ Investigate and resolve Out of Tolerance events identified during equipment/ instrument calibrations.
  
• Investigate product nonconformances, conduct root cause analysis, and implement corrective and preventive actions (CAPA).
  
• Track and monitor CAPA effectiveness to ensure issues are resolved and prevented.
  
• Support the Health and Hazard Evaluation process by gathering required data and performing in-depth analysis prior to sharing the information with the Field Action Committee.
  
• Implement corrective and preventive actions (CAPAs) to address root causes and prevent recurrence of quality issues.
  
• Facilitate risk management activities related to manufacturing processes, identifying, and mitigating risks to product quality, safety, and efficacy.
  
• Implement risk-based decision-making processes to prioritize quality activities and allocate resources effectively.
  
• Lead and support continuous improvement projects aimed at enhancing manufacturing processes, reducing defects, and optimizing productivity.
  
• Utilize quality tools and methodologies, such as Six Sigma, Lean Manufacturing, and Statistical Process Control (SPC), to drive process optimization and waste reduction.
  
• Ensure compliance with applicable regulations, including FDA Quality System Regulation (QSR), ISO 13485, and other international standards.
  
• Support both internal and external audits as an SME for Production & Process Controls and presents records of activities related to Design Transfer for New Product Development and Design Changes.
  

Minimum Requirements

• 
  
• Bachelor's degree in engineering, Science, or other related field is required.
  
• Six Sigma Green Belt or other applicable certifications are a plus.
  
• Minimum 1 year experience in Quality or Engineering.
  
• Experience in a medical device or pharmaceutical industry.
  
• Experience with Class III disposable and/or Electro-Mechanical medical devices is preferred.
  
• Knowledge and understanding of the US Food and Drug Administration (FDA) 21 CFR 820, ISO 13485, ISO 14971, EU MDD, and EU MDR. Knowledgeable on specific requirements for Design Controls and Risk Management is preferred.
  
• Knowledge of application & selection of Sampling Plans, to support Risk based Manufacturing Controls Plans.
  
• Project management and leadership experience is desirable.
  
• Knowledge of Microsoft Office Products such as Word, Excel, or equivalent software applications.
  

Required Knowledge, Skills and Abilities

• 
  
• Strong analytical and problem-solving skills.
  
• Excellent communication and interpersonal skills.
  
• Proficiency in quality tools and methodologies (e.g., Six Sigma, FMEA, Gage R&R).
  
• Ability to work effectively in a cross-functional team environment.
  
• Ability to review and understand technical standards and their requirements for products.
  
• Lead improvement initiatives, either independently or as part of cross-functional teams
  

The base salary for this the position is a minimum salary of $87,000 and a maximum of $90,000 with 8% annual bonus

About us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

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:

• 
  
• 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:
  
  • 
    
  • 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:

• 
  
• 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:

• 
  
• 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 (

Avantor | NuSil is looking for a Quality Control Supervisor to join our team supporting manufacturing of high-purity silicone products. In this role you will provide leadership, technical, and strategic guidance, supporting quality operations for chemical manufacturing in an ISO 9001 and AS9100 certified environment.You will also drive and engage with continuous improvement activities to support the QC lab and overall business objectives.

This role will be a full-time, 2nd shift: 3:00pm - 11:30pm, onsite position based out of our Carpinteria, CA facility.If you are a transformative leader seeking an exciting opportunity to drive quality initiatives - let's talk!

What we're looking for

• Education: High School completion or equivalent (GED) is required; Bachelor's degree in Biology, Biochemistry, Chemistry or science related field is highly preferred
• Experience: 3 years of related/applicable lab or manufacturing experience is highly preferred
  • A proven leader, in a manufacturing and QC lab environment, that can contribute to maturing Quality functions, systems and risk-based processes to achieve business objectives
  • A quality, compliance, and business minded individual that values a growth mindset, partnerships, and collaboration
  • Excellent communication, interpersonal and people management skills
  • Demonstrated knowledge on the application of regulated quality and production risk-based processes
  • Strong analytical and problem-solving skills
• Collaboration Tool: Familiarity with MS Office (Word, Excel, Access)
• Preferred Qualifications:
  • Minimum 1 year of supervisory experience and/or leading a team
  • Preferred experience in quality systems, quality assurance, and quality control
  • Experience with a regulated ISO 9001 and/or AS9100 manufacturing environment

How you will thrive and create an impact

• Directly supervises the quality control staff, monitor individual skills and abilities for most efficient operation; follow progress of work; anticipates or investigates delays of inadequate performance; take corrective action within limits of established practice; aid other departments as needed.
• Provides on the floor and technical support to quality control associates
• Support and enforce the quality system, regulatory policies and work instructions.
• Maintain quality and quantity of output; arrange for equipment, materials and supplies to be available for work assignments; see that equipment is given proper care; troubleshoot faulty operations to determine cause and arrange for required repair and maintenance.
• Provide or arrange for training and cross-training to employees in the performance of duties; assist and instruct personnel as necessary to insure proper flow of work through department.
• Provide guidance to all level Technicians including test methods, analytical technique, good laboratory practice, paperwork completion, equipment, schedule interpretation, and LIMS support.
• Review and approval of controlled Quality Control documents including but not limited to: specifications, procedures, work instructions, validation protocols and validation reports.
• Ensure department documents and procedures are up to date and reflect current practice; revising procedures & processes when needed.
• Performs investigations for laboratory out of specification results, safety related incidents and/or processes related to the QC laboratory.
• Work with customers, regulatory agents and vendors during audits and site visits.
• Understands regulatory requirements for 21 CFR820, ISO 17025, EXCiPACT, GLP, GMP including USP/EP general practices and procedures.
• Proactively maintains current industry and regulatory knowledge for medical devices, ISO 17025, GMP principles and current analytical technology.
• Assist in determining priority of urgent items and appropriate action plan to effectuate priority.
• Approve rejections and rework actions as recommended by Quality Control Technicians.
• Enforce prescribed safety rules and regulations; insure that work areas are maintained in a neat and orderly condition; perform safety and security procedures to open and close buildings and facilities.
• Performs other duties as assigned.

KNOWLEDGE SKILLS AND ABILITIES (Those necessary to perform the job competently)

• Strong interpersonal and organizational skills
• Ability to work in a team environment
• Ability to identify and resolve issues
• Strong decision making skills
• Ability to lead a team and provide guidance
• Strong attention to detail
• Strong communication skills

ENVIRONMENTAL WORKING CONDITIONS & PHYSICAL EFFORT (Under Typical Positions)

Typically works in a lab environment with adequate lighting and ventilation and a normal range of temperature and noise level. At times, may be exposed to a variety of different chemicals including flammables, corrosives, oxidizers and others.

Work assignments are diversified. Examples of past precedent are used to resolve work problems. New alternatives may be developed to resolve problems.

A frequent volume of work and deadlines impose strain on routine basis.

Minimal physical effort is required. Work is mostly sedentary but does require walking, standing, bending, reaching, lifting or carrying objects that typically weigh less than 10 lbs.

#LI-Onsite

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.

Why Avantor?

Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.

The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor.

We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today!

Pay Transparency:

The expected pre-tax pay for this position is

Actual pay may differ depending on relevant factors such as prior experience and geographic location.

EEO Statement:

We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.

If you need a reasonable accommodation for any part of the employment process, please contact us by email at let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

For more information about equal employment opportunity protections, please view the Know Your Rights poster.

3rd Party Non-Solicitation Policy:

By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation.

Avantor, a Global Fortune 500 company, is looking for a dedicated Quality Assurance Technician/ Inspector to optimize our BPS manufacturing/QARA organization.

This Aurora, OH role is full-time, working on-site Monday through Friday 3- 11:30 PM.

Minimum Education Requirement:

• High school diploma/GED

Required Experience (2+ yrs):

• In a GMP environment
• With quality assurance in a manufacturing environment
• Collaboration skills (IE: Microsoft Office).
• Analytical and problem solving
• Record keeping

Preferred Experience:

• Assisting in the planning, development and implementation of quality assurance programs

How you will thrive and create an impact:

Avantor is a leading life sciences company and global provider of mission-critical products and services to the life sciences and advanced technology industries. A GMP manufacturing facility, the Aurora, OH location specializes in manufacturing biochemicals.

Utilizing business level interpersonal, written and oral skills while adapting readily to change and managing multiple priorities; the role of the second shift QA Technician is to provide support to Avantor's customers, quality management system programs (including cGMP and ISO), and the manufacturing operation. This position plays a vital role in facilitating Avantor's success through quality monitoring, compliance adherence, and continuous improvement.

The Quality Assurance Technician will:

• Inspect shipments, reconcile labels, review and release finished products.
• Review QC testing documentation and results for conformance.
• Confirm expiration dating and issue certificates of analysis for each lot.
• Review, approve, reject quality related documents.
• Respond to customer requests, including, but not limited to, investigating complaints.
• Completing required paperwork for corrective and preventive actions and associated follow-up.
• Maintain ISO and cGMP paperwork.
• Conduct root cause analysis.
• Ensure the quality requirements of all departments are being followed and are accurately documented.
• Complete pm/calibration documentation files.
• Manage out of service equipment.
• Assure validations are performed according to approved protocols and samples provided as requested.
• Prepare routine, technical, and special presentations/reports.
• Prepare/ compile statistical analysis of quality assurance data.
• Coordinate and perform quality assurance system internal audits.
• Investigate non-conformances and determine root cause analyses.
• Review current policies determining and documenting any areas that may require quality improvements.
• Adhere to manufacturing procedures/ processes.
• Follow standard operating procedures (SOPs).
• Work in a team environment.
• Work in an organized manner with attention to detail.
• Perform other duties as assigned.

Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.

Why Avantor?

Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.

The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor.

We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today!

EEO Statement:

We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.

If you need a reasonable accommodation for any part of the employment process, please contact us by email at let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

For more information about equal employment opportunity protections, please view the Know Your Rights poster.

3rd Party Non-Solicitation Policy:

By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation.

*At Securian Financial the internal position title is Infrastructure Dir."

Mission

"To lead the engineering discipline that ensures Securian's technology platforms and cloud services are built and operated with uncompromising resilience, performance, and quality. This role drives the design and automation of fault-tolerant, high-availability architectures across AWS, Azure, and GCP-ensuring the enterprise meets resiliency, scalability, and efficiency expectations at every layer of technology."

Positioning

The Director of Resilience Engineering and Quality Leader is both a strategic peer and technical counterpart to the Infrastructure & Reliability Engineering Leader.

This role provides bench depth and succession coverage for REO's most technically complex domains while driving innovation in reliability, resilience, and performance practices.

• Strategic influence: Shapes cloud reliability, quality engineering, and resilience strategy across REO and Architecture domains.

• Operational authority: Leads Sr. Managers and Managers who own the execution of quality, resilience, and performance engineering capabilities.

• Enterprise collaboration: Works hand-in-hand with Technology, Solution, Business, Data, and Enterprise Architects to embed reliability and resilience as core architecture principles.

Scope of Accountability

Resilience Engineering & Cloud Reliability

• Architect and validate fault-tolerant, regionally resilient architectures across AWS, Azure, and GCP.

• Own resilience automation, chaos testing, and IaC-based recovery validation.

• Lead cross-cloud reliability design reviews and failure-mode analyses for critical systems.

Quality Engineering & Continuous Testing

• Define enterprise-wide quality engineering strategy integrated into CI/CD pipelines.

• Drive automation-first testing (functional, non-functional, performance, resilience).

• Embed observability-driven quality validation and contract testing across services.

Performance, Capacity & Efficiency Engineering

• Oversee predictive capacity planning, scaling automation, and cost/efficiency optimization (FinOps/GreenOps).

• Partner with Platform & Infrastructure teams to tune performance across application and platform layers.

• Measure and report on performance SLIs/SLAs aligned to REO's Reliability Metrics framework.

Cross-Domain Architecture Collaboration

• Partner with Enterprise Architects to codify resilience and reliability standards in technology blueprints.

• Collaborate with Technology & Solution Architects to design service reliability into delivery architectures.

• Engage Data Architects for data resilience, replication, and pipeline reliability.

• Work with Business Architects to align technical reliability goals with critical business outcomes.

Leadership & Talent Development

• Lead a team of Sr. Managers and Managers, fostering a high-performance, hands-on engineering culture.

• Build and mentor top-tier technical talent in cloud reliability, resilience, and quality automation.

• Partner with HR and REO Enablement to develop succession plans and technical competency frameworks.

Core Technical Competencies

• AWS (primary) - Multi-account design, HA architecture, region failover, resilience automation, Terraform/CDK/CloudFormation.

• Azure & GCP (secondary) - Compute, networking, and reliability constructs; hybrid cloud design and failover integration.

• Infrastructure as Code (IaC) - Deep proficiency in Terraform, policy-as-code (OPA/Conftest), drift detection, pipeline integration.

• Reliability & Chaos Engineering - AWS Fault Injection Simulator, Gremlin, steady-state hypothesis design.

• Observability & Quality Automation - OpenTelemetry, Prometheus, CloudWatch, K6, Gatling; CI/CD quality gates and dashboards.

• Performance Engineering - Load, stress, and soak testing automation; performance profiling and SLO alignment.

• Disaster Recovery Automation - Cross-region orchestration, IaC-driven DR runs, replication validation.

• FinOps/GreenOps - Cloud cost and efficiency automation, carbon-aware scaling policies.

Leadership Competencies

• Strategic Technical Leadership: Operates at the intersection of deep engineering and executive strategy.

• Multi-Domain Collaborator: Integrates reliability and resilience across architecture, operations, and business domains.

• Talent Multiplier: Develops and empowers senior managers, fostering engineering mastery and innovation.

• Credible Technical Authority: Trusted peer to Infrastructure & Reliability Engineering; capable of leading architecture reviews and executive briefings.

• Change Champion: Drives transformation of reliability practices across platforms, pipelines, and teams.

Qualifications & Experience

• 12+ years in cloud engineering, reliability, or platform leadership roles.

• 5+ years leading Sr. Managers/Managers in technical domains.

• Proven expertise across AWS, with working knowledge of Azure and GCP.

• Experience with multi-cloud governance, DR design, IaC at scale, and reliability automation.

• Strong understanding of observability, SRE principles, and REO/ITIL-aligned reliability frameworks.

• Certifications:

  • Required: AWS Certified Solutions Architect - Professional

  • Preferred: AWS DevOps Engineer, Azure Solutions Architect Expert, Google Professional Cloud Architect

Success Metrics

• 99.9% availability maintained for Tier-1 workloads.

• 100% coverage of DR automation for Tier-1 services.

• 25% annual increase in automated quality/test coverage.

• 15% annual improvement in resource efficiency and cost performance.

• Documented resilience participation across all enterprise architecture blueprints.

• Positive "technical peer readiness" and succession rating from Head of REO.

Summary Value Proposition

This Director role blends deep AWS reliability engineering expertise, multi-cloud technical breadth, and leadership scale.

It ensures REO maintains both technical depth and leadership redundancy, and it strengthens the bridge between engineering execution and enterprise architecture alignment.

#LI-hybrid **This position will be in a hybrid working arrangement.**

Securian Financial believes in hybrid work as an integral part of our culture. Associates get the benefit of working both virtually and in our offices. If you're in a commutable distance (90 minutes), you'll join us 3 days each week in our offices to collaborate and build relationships. Our policy allows flexibility for the reality of business and personal schedules.

The estimated base pay range for this job is:

Pay may vary depending on job-related factors and individual experience, skills, knowledge, etc. More information on base pay and incentive pay (if applicable) can be discussed with a member of the Securian Financial Talent Acquisition team.

Be you. With us. At Securian Financial, we understand that attracting top talent means offering more than just a job - it means providing a rewarding and fulfilling career. As a valued member of our high-performing team, we want you to connect with your work, your relationships and your community. Enjoy our comprehensive range of benefits designed to enhance your professional growth, well-being and work-life balance, including the advantages listed here:

Paid time off:

• We want you to take time off for what matters most to you. Our PTO program provides flexibility for associates to take meaningful time away from work to relax, recharge and spend time doing what's important to them. And Securian Financial rewards associates for their service by providing additional PTO the longer you stay at Securian.

• Leave programs: Securian's flexible leave programs allow time off from work for parental leave, caregiver leave for family members, bereavement and military leave.

• Holidays: Securian provides nine company paid holidays.

Company-funded pension plan and a 401(k) retirement plan: Share in the success of our company. Securian's 401(k) company contribution is tied to our performance up to 10 percent of eligible earnings, with a target of 5 percent. The amount is based on company results compared to goals related to earnings, sales and service.

Health insurance: From the first day of employment, associates and their eligible family members - including spouses, domestic partners and children - are eligible for medical, dental and vision coverage.

Volunteer time: We know the importance of community. Through company-sponsored events, volunteer paid time off, a dollar-for-dollar matching gift program and more, we encourage you to support organizations important to you.

Associate Resource Groups: Build connections, be yourself and develop meaningful relationships at work through associate-led ARGs. Dedicated groups focus on a variety of interests and affinities, including:

• Mental Wellness and Disability

• Pride at Securian Financial

• Securian Young Professionals Network

• Securian Multicultural Network

• Securian Women and Allies Network

• Servicemember Associate Resource Group

For more information regarding Securian's benefits, please review our Benefits page.

This information is not intended to explain all the provisions of coverage available under these plans. In all cases, the plan document dictates coverage and provisions.

Securian Financial Group, Inc. does not discriminate based on race, color, religion, national origin, sex, gender, gender identity, sexual orientation, age, marital or familial status, pregnancy, disability, genetic information, political affiliation, veteran status, status in regard to public assistance or any other protected status. If you are a job seeker with a disability and require an accommodation to apply for one of our jobs, please contact us by email at , by telephone (voice), or 711 (Relay/TTY).

To view our privacy statement click here

To view our legal statement click here

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.

Join Yorke Engineering, LLC, an Environmental Consulting leader in California that implements Environmental Engineering and Compliance solutions for our clients throughout California. Our mission is to solve environmental compliance problems for industrial and governmental/infrastructure facilities. We are a growing and dynamic organization of highly respected professionals. Yorke Engineering, LLC has assisted over 1,400 client organizations with their Air Quality and Environmental Compliance, Engineering, and Permitting needs. Our philosophy is to efficiently help government and industrial customers with the complex array of environmental laws and regulations. From simple permits to complex agency negotiations, from small companies to the largest of California’s organizations, Yorke successfully solves our clients’ Air Quality and Environmental challenges. Our team has over 1,000 years of combined environmental experience and consists of engineers and scientists that specialize in Air Quality, Waste, Water, CEQA, Safety, and Industrial Hygiene.

We are looking for a sharp Principal Air Quality Engineer/Scientist (Environmental Permitting and Compliance) to join our team in Northern CA. This is a full-time position at 40 hours per week in the bay area. We currently have offices in Berkeley and San Francisco but may open a new office based on candidate location. We offer competitive salaries, a full benefits package including Paid Time Off, Holidays, Full Medical/Dental/Vision, along with a 401k program with a generous company match.

Position Summary:

The Principal Air Quality Engineer/Scientist (Environmental Permitting and Compliance) performs professional engineering work, leading and executing the compliance and permitting functions in relation to Air Quality Regulations and Compliance. This candidate will be reviewing processes and equipment, analyzing permit-related technical and regulatory issues, and communicating those analyses within Yorke, the client organization, with government agencies and with the public at large. The work is challenging, broad in scope, and variable from project to project. The position involves effective communication, decision-making, and time management. The candidate performs other duties as required or assigned.

This is a Principal level position. Positions at this level are assigned to perform the more complex and sensitive duties within air quality consulting. The employee in this position will be assigned to develop business, write proposals, train and mentor other employees, and/or monitor work produced by other employees.

The candidate’s experience and qualifications we are seeking include:

• 15-25+ years of work experience in the Air Quality and/or Environmental industry in an engineering role (preferably in a consulting environment);
• Experience in the environmental services industry focusing on leading Air Quality services:
• Process and equipment review;
• Air quality permitting under BAAQMD, SCAQMD, SJVAPCD and other Air Districts, including Title V Permitting;
• Annual Emissions Reporting;
• Air Dispersion Modeling;
• Air Quality Assessments including Data Analysis and Emission Inventories;
• General Air Quality Compliance for facilities in CA.
• Ability to manage and lead active team members on project teams towards project completion within project scope, budget and schedule and ensure quality work product and deliverables;
• Ability to manage successful relationships with clients, staff, and regulators through effective communication and expertise by fostering a collaborative environment without losing focus of quality;
• Proven track record or desire to engage in successful regulatory work in dealing with the SCAQMD, BAAQMD, SJVAPCD, EPA, CARB and/or other similar regulatory agencies;
• Experience working on-site at client facilities;
• Prepare reports and submissions in timely manner;
• Experience with handling highly technical data and technical data interpretation;
• Highly motivated to continue working in Air Quality environmental field and expand their knowledge and experience;
• CA Regulatory/Compliance experience is required.

Job Requirements:

• B.S or M.S. degree in Chemical Engineering, Environmental Engineering, or Mechanical Engineering, or other relevant technical degrees from an accredited college;
• Ability to work collaboratively in a team fashion, handle several projects at once, prioritize work, and work efficiently;
• Desire to train and share technical expertise in environmental rules and regulations with clients and team members;
• Excellent oral and written communications skills;
• Experience in conflict resolution and crisis management;
• Track record of successful analysis, interpretation, and application of rules and regulations towards practical solutions;
• Ability to think critically and develop solutions;
• Software Knowledge:
• Strong Microsoft Excel, Word, Outlook, and Powerpoint skills (required);
• Microsoft 365 Applications, including Sharepoint (a plus)
• P.E. Certification (a plus).

The Quality Manager is responsible for leading and maintaining the company’s Quality Management System (QMS) in compliance with AS9100, FAA, EASA, NADCAP, and customer-specific aerospace requirements. This role ensures product conformity, regulatory compliance, continuous improvement, and customer satisfaction within a precision aerospace manufacturing environment.

The Quality Manager provides strategic leadership across Quality Assurance, Quality Control, Inspection, and Continuous Improvement functions while fostering a culture of accountability, safety, and operational excellence.

Key Responsibilities

Quality Management System (QMS)

• Maintain and improve the AS9100-compliant Quality Management System.
• Ensure compliance with FAA, EASA, ITAR, NADCAP, and customer-specific requirements.
• Lead internal and external audits (customer, registrar, regulatory).
• Serve as primary point of contact for regulatory agencies and certification bodies.
• Manage document control, change management, and quality records retention.

Product Quality & Compliance

• Oversee inspection, testing, and release of aerospace components and assemblies.
• Ensure First Article Inspections (FAI) per AS9102 requirements.
• Review and approve corrective and preventive actions (CAPA).
• Lead root cause analysis (8D, 5-Why, Fishbone, RCCA).
• Ensure nonconforming material control and disposition (MRB participation).

Customer & Supplier Quality

• Interface with customers on quality performance, audits, and corrective actions.
• Manage customer complaints and drive timely resolution.
• Oversee supplier quality performance and approval processes.
• Support supplier audits and quality development initiatives.

Team Leadership

• Lead and develop Quality Engineers, Inspectors, and Technicians.
• Establish departmental KPIs and performance metrics.
• Provide training on quality standards, regulatory requirements, and procedures.
• Foster a culture of continuous improvement and accountability.

Continuous Improvement

• Drive Lean, Six Sigma, and risk-based thinking initiatives.
• Monitor quality metrics (PPM, scrap, rework, COPQ, on-time delivery impact).
• Lead risk assessments and mitigation strategies (FMEA).
• Support operational excellence and cost reduction initiatives.

Reporting & Metrics

• Present quality performance reports to executive leadership.
• Track and analyze trends in defects, escapes, and audit findings.
• Maintain quality dashboards and compliance metrics.

Qualifications

Education

• Bachelor’s degree in Engineering, Quality, or related technical field required.
• Master’s degree preferred.

Experience

• 7–10+ years of quality experience in aerospace manufacturing.
• Minimum 3–5 years in a leadership role.
• Strong knowledge of AS9100 and AS9102 standards.
• Experience with FAA Part 21/145 regulations (as applicable).
• NADCAP experience preferred.
• Experience in machining, fabrication, composites, or precision manufacturing preferred.

Certifications (Preferred)

• ASQ Certified Quality Manager (CQM)
• ASQ Certified Quality Engineer (CQE)
• Six Sigma Green or Black Belt
• Lead Auditor certification (AS9100)

The Director of Quality & Regulatory Affairs (DQRA) is responsible for assisting the Chief Quality Officer (CQO) with the execution of the SFDN Quality Management System including continual quality improvement throughout the organization. Directs the development, implementation and monitoring of quality systems and regulatory compliance related to internal standards, industry standards, state, local and federal regulations, departmental and organizational goals and processes. Assist with the overall direction for consistency and training for those managed. The Director serves as an advocate and resource for quality programs and provides interpretations of regulations and standards for consideration in the formulation of business strategies related to organ, tissue, and ocular recovery as well as administrative operations.

ESSENTIAL FUNCTIONS

Essential Functions Statement(s)

• Directs, manages, and provides oversight for all activities related to the Quality Management System (QMS) and performance improvement.

o Develops and maintains a quality plan to ensure the best service possible. Oversees the implementation of the SFDN’s QMS. At a minimum, activities will include and are not limited to Licensing, Performance Improvement, Customer Complaint, Planned Deviation, Corrective Action/Preventive Action, Auditing, Document Control, Chart QA, Validation, and Death Record Review Systems.

o Promotes quality assurance with the expectation of accurate donor medical records and data elements, and validation of all performance data.

o Implements, monitors and reviews systems and programs instituted to provide consistent adherence to policies related to organ, tissue and ocular recovery, laboratory, and administrative operations.

o Responsible for the administration of the electronic quality management system platform.

• Ensures organizational compliance with regulatory standards including AHCA, AOPO, OPTN/HRSA, CDC, and CMS. Ensures all regulatory and governmental licenses are kept current.

a. Monitors and analyzes information release and activity pertaining to federal, state, and industry standards as it relates to regulatory compliance and organizational operations.

b. Ensures policies and procedures reflect regulations and standards and collaboratively leads the revision of policies and procedures, as needed to reflect any applicable regulatory changes.

• Will be listed as the Patient Safety Contact with OPTN/HRSA as well as serve as the Patient Safety Officer.

a. The Patient Safety Officer will be responsible for monitoring and investigating patient safety events in real time, serving as the first point of contact for families, hospital partners, and HRSA; documenting and reporting incidents and adverse events to OPTN.

• Develops, oversees and maintains a quality plan that aligns to the SFDN Quality Manual and Quality Excellence Program (QEP) in order to advance the SFDN mission and core purpose.

• Deploys and maintains an effective QMS to foster a culture of continuous improvement through data analysis in collaboration with all SFDN departments.

a. Promotes use of the organization’s quality improvement process by evaluating, improving, improving workflow, and maximizing process efficiencies.

• Assists in the development and analysis of all statistical performance measurements of organ, tissue, and administrative operations, and quality and regulatory compliance throughout the organization. Conducts ongoing monitoring and data analysis, trending and reporting of the quality management systems including but not limited to occurrences (non-conformances), planned deviations, customer complaints, sentinel events, and adverse reactions and outcomes. Identify opportunities for improvements.

a. Reports meaningful data related to activity levels, quality measures, and regulatory compliance to SFDN leadership, staff, advisory board members, and various stakeholders.

• Collaborates with other organ, tissue and recovery agencies to keep current on industry best practices and works to deploy the same in the organization.

• Represents SFDN at various meetings and conferences including the Association of Organ Procurement Organization (AOPO). Promotes SFDN and the brand through actively participating and presenting at these conferences.

• Manages the selection, training, development, and performance of assigned staff to retain a motivated, professional workforce for the department.

• Recruits and selects applicants for job vacancies considering the requirements of the job and the skills/abilities of the applicants.

• Establishes and communicates job responsibilities as well as employee performance expectations to assure mutual understanding of desired results.

• Identifies training and/or development opportunities that will assist the employee in achieving enhanced job performance and/or career objectives.

• Constructively coaches and counsels for success to seek optimal employee performance.

• Builds support and alliances between and among departments to promote the organizational core values.

• Conducts performance reviews in alignment with job expectations, as well as reviews salary accordingly.

• Develop and maintain an internal audit program to ensure the application of organization policies and procedures as well as the adherence to applicable regulatory and accrediting regulation and standard requirements in the actions of the organization.

a. Oversees all phases of audits initiated by regulatory agencies and external customer-initiated audits.

b. Liaison for formal resolutions to compliance concerns brought forth by auditors including regulatory bodies.

c. Oversees all phases of the organization’s qualification audits of its vendors.

• Maintains the document control system for the organization

a. Assists in the review, creation, update, and maintenance of all organizational standard operating policies and procedures. Ensures that all policies and procedures are in compliance with applicable local, state, federal, and industry standards and regulations.

b. Utilizes the electronic quality management system platform to maintain the document control system for the organization’s-controlled documents.

c. Ensures all staff receive and adequately complete read acknowledgement training on all relevant controlled documents.

• Manages the non-conformance reporting system to ensure adequate and effective corrective and preventive actions are taken.

• Oversight for positive serology reporting in accordance with local, state, and federal regulations and accrediting standards.

• Oversight for organizational training related to quality tools through internal and external sources.

• Plan and uphold departmental budget through strategic planning in collaboration with Senior Leadership Team to support the goals of the organization.

• As appropriate, develops or assists in development of verification or validation of equipment, processes, and electronic systems.

• Perform other duties as assigned.

• Employees must adhere to and remain in full compliance with South Florida Donor Network’s Motor Vehicle Driving Policy as outlined in the Motor Vehicle Records and Driver Safety policy PC.334.

SKILLS & ABILITIES

Education: Bachelor's Degree in business or healthcare field; Master’s Degree preferred; years of experience may be considered in lieu of education.

Experience: Two to four years related experience in organ/tissue/ocular donation or healthcare related field and in supervision or management of others

Computer Skills: Knowledge of MS office programs

Certificates & Licenses: Six Sigma Black Belt, but not required. ASQ required

Other Requirements: None

Kelly Science & Clinical is seeking a proactive Quality Assurance Coordinator for a specialty chemical company in Baytown, TX. This role is critical in ensuring compliance with quality regulations (federal, state, and local), improving processes, and implementing effective quality management systems. The ideal candidate will have experience in implementing quality programs, conducting and documenting risk assessments, and possess the initiative to follow through on projects until the desired results are achieved.

Key Responsibilities:

• Develop, implement, and maintain quality management systems
• Ensure compliance with relevant industry standards and regulations
• Conduct regular audits and inspections of raw materials, in-process products, and finished goods
• Monitor and analyze quality performance data, identifying areas for improvement
• Identify safety hazards, support incident investigation, and ensure proper reporting to find root cause analysis and corrective actions
• Collaborate with cross-functional teams to drive continuous improvement initiatives
• Provide training and support on quality procedures and best practices

Qualifications:

• Bachelor’s degree in Chemistry, Chemical Engineering, Quality Management, or related field is preferred
• Proven experience in quality assurance/control within a chemical manufacturing environment
• Knowledge of quality standards and regulations relevant to the chemical industry
• ISO 9001 knowledge / certification
• Strong analytical and problem-solving skills
• Excellent communication and teamwork abilities
• Proficiency in quality management software and MS Office Suite

This is a Direct Hire position with a Monday-Friday day shift work schedule. If you meet the above qualifications, please submit your resume for immediate consideration.