Quality Custom Distribution Jobs in Usa
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Evaluate production process, recommend improvements, qualify and conduct vendor management, generate and maintain DMR’s, product specifications, design control files, and CE technical files.
Job Description MAJOR RESPONSIBILITIES: Manage the development and implementation of methods and procedures for process control, process validation, process improvement, testing, and inspection to ensure that products are ideal and functional.
Design experiments to understand sources of variation affecting products and processes.
Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes.
Design and perform experimental product testing and analysis to maintain quality levels and minimize defects and failure rates.
Generate and analyze reports and defective products to determine trends and lead corrective actions.
Use concepts of probability and statistical quality control to guide decisions.
Direct and collaborate with supplier representatives on quality problems, ensure corrective action implementation (CAPA, SCAR), and contribute to supplier quality improvement programs.
Lead supplier qualifications.
Provide Quality expertise in Product Development, Design Control activities, Risk Management, and CE Technical Files.
Responsible for building appropriate product documentation (e.g.
Device Master Records) in compliance with applicable regulations.
Work with Regulatory Groups and Suppliers to produce 510K submissions, letters to file, etc., as required.
Coordinate product testing with internal and external laboratories as required.
Ensure compliance with domestic and international regulations associated with product lines and processes.
Perform quality reviews of design documentation for compliance with stated requirements, including vendor quality documents and company quality records.
Lead investigations of product and process non-conformances and out-of-specification results and develop effective corrective and preventive actions (CAPA).
Education: Typically requires a Bachelor’s degree in Engineering, Science, Math or other related technical field.
Work Experience: At least 2 years of experience in the Quality or Engineering.
Knowledge / Skills / Abilities: Experience developing ways of accomplishing goals with little or no supervision, depending on oneself to complete objectives, and determining when escalation of issues is necessary.
Experience using time management skills to prioritize, organize, and track details in order to meet deadlines of multiple projects.
Experience problem solving, overcoming obstacles, and reaching a positive and successful solution through mathematical or systematic operations.
Experience using MS Office Suite products (Word, Excel, PowerPoint, Outlook ).
Intermediate Skill Level in Microsoft Excel (for example: conditional formatting, tables, formulas, charting) Working knowledge of government and industry quality assurance codes and standards (e.g.
21 CFR 820, ISO13485).
Position requires up to 15% travel.
PREFERRED JOB REQUIREMENTS: At least 2 years of industry experience in Medical Devices, Drugs, and/or fields directly related to the role.
Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
The anticipated salary range for this position: $79,000.00
- $119,000.00 Annual The actual salary will vary based on applicant’s location, education, experience, skills, and abilities.
This role is bonus and/or incentive eligible.
Medline will not pay less than the applicable minimum wage or salary threshold.
Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average.
For a more comprehensive list of our benefits please click here .
For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.
We’re dedicated to creating a Medline where everyone feels they belong and can grow their career.
We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best.
Explore our Belonging page here .
Medline Industries, LP is an equal opportunity employer.
Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.
At Boeing, we innovate and collaborate to make the world a better place. We’re committed to fostering an environment for every teammate that’s welcoming, respectful and inclusive, with great opportunity for professional growth. Find your future with us.
Boeing Commercial Airplanes (BCA) is looking for Quality Workplace Coaches (QWPC) to support the 737 Northline, 767, 777, Composite Wing Center (CWC), Interiors Responsibility Center (IRCWA) and Electrical Systems Responsibility Center (ESRC) teams onsite in Everett, Washington on 1st and/or 2nd shift.
Our team is currently hiring for a broad range of experience levels, including Experienced and Senior Quality Workplace Coaches.
We are looking for outgoing and knowledgeable Quality Workplace Coaches who are passionate about coaching, motivating, and inspiring others. In this role, you will support quality inspectors and oversee Structured On-The-Job activities. The ideal candidates will be Subject Matter Experts (SMEs) in various inspection methods and quality processes, with current hands-on experience and up-to-date proficiency in Non-Conformance Record (NCR) writing. Strong collaboration skills, natural coaching and leadership abilities, and a genuine talent for connecting with others are essential. Our team lives by the motto: “We Make People Awesome.”
Position Responsibilities:
- Coaches Quality inspectors on best practices in inspection techniques and performance improvement, utilizing expertise in quality manufacturing and assembly across various areas such as Structures, Seal, Flightline processes, Functional Test, Wings, Interiors, Electrical, WIRS, NCR Tag Writing, Hydraulics, Engines, Paint, Systems, Final Assembly, Plumbing and PDD (including but not limited to REDARS, PSDS, ONEPPM, D Documents Navigation), to enhance coaching, performance improvement, and problem solving in support of the Boeing Production System
- Analyzes and interprets performance and quality data (e.g. CMES, EPES) to identify improvement opportunities
- Analyzes processes and supports problem solving, develops, communicates and documents innovative solutions in support of area quality goals
- Assists Quality managers and team leads with Structured On-the-Job Training (SOJT) plans and provides program/job specific advanced skills coaching
- Offers Subject Matter Expertise for specific Quality skills through Workplace Coaching
- Provides coaching, positive modeling, and observation opportunities to help team members excel
- Encourages questions to ensure understanding and gives timely feedback on performance
- Reinforces efforts and progress while clarifying expected behaviors, knowledge, and proficiency levels
- Fosters good interpersonal relationships through helping team members feel valued, appreciated and included in discussions
Basic Qualifications (Required Skills/Experience):
- 3+ years of experience as a Quality Inspector
- 3+ years of experience in aerospace, fabrication, or manufacturing environment
- 3+ years of experience in aircraft manufacturing working with assembly processes and procedures
- 3+ years of experience utilizing and following detailed work instructions, reading and interpreting blueprints, drawings, or specifications
Preferred Qualifications (Desired Skills/Experience):
- 5+ years of related work experience or an equivalent combination of education and experience
- Bachelor’s degree or higher preferred
- Quality inspection experience in three or more of these areas: Quality inspection in Structures, Seal, Flightline processes, Functional Test, Wings, Interiors, Electrical, WIRS, NCR Tag Writing, Hydraulics, Engines, Paint, Systems, Final Assembly, Plumbing and PDD (including but not limited to REDARS, PSDS, ONEPPM, D Documents Navigation), to enhance coaching, performance improvement, and problem solving in support of the Boeing Production System
- Proficiency with MS Office applications
- Excellent analytical, communication and problem-solving skills
Drug Free Workplace:
Boeing is a Drug Free Workplace (DFW) where post offer applicants and employees are subject to testing for marijuana, cocaine, opioids, amphetamines, PCP, and alcohol when criteria is met as outlined in our policies.
Shift:
This role is primarily first or second shift; however, there may be additional shift requirements to support program objectives.
Total Rewards:
At Boeing, we strive to deliver a Total Rewards package that will attract, engage and retain the top talent. Elements of the Total Rewards package include competitive base pay and variable compensation opportunities.
The Boeing Company also provides eligible employees with an opportunity to enroll in a variety of benefit programs, generally including health insurance, flexible spending accounts, health savings accounts, retirement savings plans, life and disability insurance programs, and a number of programs that provide for both paid and unpaid time away from work.
The specific programs and options available to any given employee may vary depending on eligibility factors such as geographic location, date of hire, and the applicability of collective bargaining agreements.
Pay is based upon candidate experience and qualifications, as well as market and business considerations.
Summary pay range:
Experienced (Level 3): $102,500 - $114,000
Senior (Level 4): $126,000 - $140,000
Applications for this position will be accepted until Mar. 20, 2026
Export Control Requirements:
This position must meet U.S. export control compliance requirements. To meet U.S. export control compliance requirements, a “U.S. Person” as defined by 22 C.F.R. §120.62 is required. “U.S. Person” includes U.S. Citizen, U.S. National, lawful permanent resident, refugee, or asylee.
Export Control Details:
US based job, US Person required
Relocation
Relocation assistance is not a negotiable benefit for this position.
Visa Sponsorship
Employer will not sponsor applicants for employment visa status.
Shift
This position is for 1st shift
Equal Opportunity Employer:
Boeing is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, physical or mental disability, genetic factors, military/veteran status or other characteristics protected by law.
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.
Avantor, a Global Fortune 500 company is looking for a dedicated Quality Assurance Engineer/ Food Safety to optimize our BPS manufacturing/ QARA organization. This Aurora, OH role is full-time, on-site.
Minimum Education Requirement:
- Bachelor's degree
Required Experience (4+ yrs):
- Leading, coordinating and maintaining a site food safety program FSSC Certification
- Applying quality engineering principles, tools and techniques to develop and optimize systems and processes so that they are aligned with company strategy and regulatory requirements.
- Using root cause analysis and risk assessment tools and techniques to perform investigations and determine appropriate corrective action.
- FSSC (Food Safety System Certifications) certification or comparable
- Reviewing and approving quality assurance procedures and reports.
- Leading, conducting and managing internal audits.
- Maintaining SOP's and Quality Management Systems
- Monitoring compliance with ISO and FDA Quality System Regulation standards.
Preferred Experience:
- Providing support for customer and regulatory audits.
- Updating approved supplier index.
- Maintaining supplier qualification documents and qualifications of service providers that assure compliance with procedures and programs.
- Deviation and complaint investigations, including root cause analysis tools and technical writing.
- Collecting, reviewing, and interpreting data for trend reports, metrics, quality system reviews and complaints.
- Participating in, coordinating and maintaining validations
- CQE/CQA certification.
- Leading, coordinating and maintaining environmental monitoring 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.
Collaborating/ interfacing effectively with team members the Quality Assurance Engineer is responsible for quality assurance activities with oversight of the food safety program. While performing other duties as assigned, this role will be accountable for:
- Leading the food safety committee
- Investigations
- Quality Management System SOP's
- Validations
- Performing Incoming Audits
- Maintaining Halal, Kosher, and FSSC 22000 certifications and all associated documentation.
- Quality continuous improvements.
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.
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 (
We're building safety-enhancing technology for aviation that will save lives. Automated aviation systems will enable a future where air transportation is safer, more convenient and fundamentally transformative to the way goods - and eventually people - move around the planet. We are a team of mission-driven engineers with experience across aerospace, robotics and self-driving cars working to make this future a reality.
As a Sr. Quality Assurance and Reliability Engineer, you'll be a part of the Production organization. You'll bring the technical leadership required to verify product safety and reliability, lead investigations, identify and implement corrective actions, and ensure improvements are implemented. This is a small but growing team of highly motivated people who are passionate about delivering quality products and services with velocity and unquestionable value. You will be responsible for the strategy and execution of the quality management system, risk mitigation, risk prevention, design reliability, hardware reliability, flight reliability, test validation, and production optimization. As Reliable Robotics continues to grow and scale, you'll be responsible for increasing the velocity of the business, maturing processes, and building automations to enable company success. The projects you work on will set the foundation for how the business operates for years to come. This is a fantastic opportunity to work in a safety-critical environment that takes automated aviation systems from prototype to production in a hands-on environment.
Responsibilities
Work with the design, manufacturing, test, and flight teams to produce reliable products, ensure compliance, and drive continuous improvement across the business. You'll have the opportunity to work directly with flight hardware in the factory and on the plane, run investigations and containment on safety-critical products, and watch your processes build the first certifiable autonomous aircraft.
Partner with design, manufacturing, and test teams through product development, acceptance testing, and quality checkouts to create reliable hardware verification for flight components and systems, including identification of key operating characteristics, prototype development testing for functionality and manufacturability, flight and prototype planning development, and collation of test anomalies and lessons learned.
Develop and manage the quality management system to ensure compliance with processes, work instructions, certifications, and regulatory requirements.
Investigate anomalies in manufacturing, supply chain, testing, and flight, identifying and mitigating the immediate and underlying root causes to manage risk and improve the reliability of designs and processes.
Support the development, manufacturing, and verification of products using continuous improvement and statistical techniques.
Develop, implement, and validate test and inspection methodologies for new and existing products, ensuring objective criteria are consistently met and quality goals are met.
Derive, automate, and report quality metrics to the business and provide recommendations for design, product, and process improvements.
Basic Success Criteria
Bachelor's Degree in Mechanical Engineering, Electrical Engineering, Aerospace, Software Engineering, or a similar advanced degree
7+ years of professional experience in design engineering, manufacturing, test, software, or quality and reliability engineering
2+ years of professional experience with investigations, design of experiments, and other investigatory and problem-solving methods
Experience with quality, risk, and/or safety management systems and processes
Preferred Criteria
2+ years of experience with Federal Aviation Administration (FAA) regulatory requirements (e.g., 14 CFR 21, DO-160, D0-254, etc.)
2+ years of programming experience in Python, C, or SQL with an emphasis on data analysis and automation
Experience evaluating, defining, strategizing, and executing test campaigns and procedures
Experience developing engineering infrastructure and tools in support of the Quality Management System (QMS)
Excellent written and verbal communication skills
Our team is passionate about delivering on our commitments, solving hard problems, continuously improving, and helping the business succeed. We are constantly reevaluating our technologies, products, and capabilities. If you are a lifelong learner, you will love this environment. Get in on the ground floor and help us build the company.
The position will be located at our facility in Mountain View, California. Must be willing to travel up to 20% of the time.
This position requires access to information that is subject to U.S. export controls. An offer of employment will be contingent upon the applicant's capacity to perform in compliance with U.S. export control laws.
All applicants are asked to provide documentation that legally establishes status as a U.S. person or non-U.S. person (and nationalities in the case of a non-U.S. person). Where the applicant is not a U.S. person, meaning not a (i) U.S. citizen or national, (ii) U.S. lawful permanent resident, (iii) refugee under 8 U.S.C. * 1157, or (iv) asylee under 8 U.S.C. * 1158, or not otherwise permitted to access the export-controlled technology without U.S. government authorization, the Company reserves the right not to apply for an export license for such applicants whose access to export-controlled technology or software source code requires authorization and may decline to proceed with the application process and any offer of employment on that basis.
At Reliable Robotics, our goal is to be a diverse and inclusive workforce. As an Equal Opportunity Employer, we do not discriminate on the basis of race, religion, color, creed, ancestry, sex, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity, gender expression, sexual orientation, age, non-disqualifying physical or mental disability or medical conditions, national origin, military or veteran status, genetic information, marital status, or any other basis covered by applicable law. All employment and promotion is decided on the basis of qualifications, merit, and business need.
If you require reasonable accommodation in completing an application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to
Compensation Range: $165K - $220K
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Senior Vice President, Quality and Safety
StartDate: ASAP
Senior Vice President, Quality and Safety
Catholic Health
Buffalo, NY
The Opportunity
Catholic Health, an integrated health system in Buffalo, New York, announces an exceptional opportunity for an accomplished nurse leader to serve as its Senior Vice President, Quality and Safety.
Reporting directly to the Executive Vice President, Chief Nursing Officer, the SVP Quality and Safety is responsible for the overall management of an experienced broad-based team charged with monitoring, reporting, educating and inspiring devotion to excelling in internal and external quality metrics for the entire enterprise with the goal of attaining and sustaining top decile performance. The SVP serves as the system liaison and senior executive for all Quality and Patient Safety collaborative initiatives with the acute care hospitals, service lines, continuing care division and homecare ministries to promote integration and alignment in an effort to improve the quality and safety outcomes across the continuum, thereby improving the patient's overall experience.
The SVP will provide leadership and guidance for the executive leaders' education and development and lead the efforts for quality improvement education, training and coaching of all Catholic Health staff. The SVP will be responsible for establishing a strategic framework for achieving the institution's goals with relation to medical care quality, education quality, research quality and patient safety. Additionally, the SVP will play a critical role in system and Catholic Medical Partners initiatives regarding population health management, quality improvement, clinical practice standardization. The SVP will also foster a culture of safety, champion high reliability and the magnet journey in addition to other cross functional activities.
The Ideal Candidate:
- A master's degree with clinical major required.
- Current registration with the New York State Education Department as a Registered Professional Nurse or ability to quickly obtain will be required.
- Minimum of 10 years of progressive quality and safety management experience in an acute care setting.
- Experience in an academic medical center and/or progressive health system of significant size and complexity preferred.
- Experience establishing and monitoring appropriate process and outcome measures for key initiatives using a systems perspective; evaluating the processes by which clinical care and patient services are delivered.
- Experience working with informatics, metrics, and performance improvement.
- Demonstrated change management skills in a complex environment.
- An inspirational leader that motivated colleagues and staff throughout the organization by clearly articulating a compelling vision for the future, making courageous decisions, following through with commitments, and demonstrating an unrelenting passion for CH mission and performance.
- Experience with tracking, reporting, and improving key quality and safety metrics.
- Experience with Lean Six Sigma methodologies.
The Organization
Catholic Health ("the System"), based in Buffalo, New York, is one of upstate New York's leading and largest integrated health care systems. The System serves a population of approximately 1.5M people in Erie County, New York, and neighboring counties. With more than 9,000 employees, a 1,600-member medical staff, and net patient service revenue of more than $1.1B, this dynamic health care system provides a comprehensive network of high quality advanced medical care, primary care, post-acute care, and senior services. These programs and services are provided across four member hospitals, multiple ambulatory care sites, four skilled nursing facilities, three home care agencies, a PACE (Program of All-inclusive Care for the Elderly) program, and community-based behavioral health services spanning 74 access points across the full continuum of care.
The Location
Buffalo, New York is located on the eastern side of Lake Erie near Niagara Falls and the Canadian border. As the second-largest city in New York State, Buffalo has more than one million people living in its metropolitan area. Coined the nickname "The City of Good Neighbors," Buffalo is notorious for its friendly residents and welcoming sense of community. With its growing population and diverse culture, it is understandable how Buffalo has become such a desirable location for young professionals and families.
Considered to be one of the best places to live in New York, many people are moving to Buffalo for its affordability, education opportunities, and employment options. Providing its residents with a mixture of urban and suburban living, Buffalo knows how to blend big-city perks with all the conveniences of suburban life.
Compensation Range: The base salary range for this position is $275,000 to $300,000 annually. In addition, a leader may be eligible for other benefits, including but not limited to health insurance coverage, retirement benefits, and bonuses. The total compensation for the finalist selected for this role will be determined based on various factors, including but not limited to scope of role, level of experience, education, accomplishments, internal equity, budget, and subject to Fair Market Value evaluation. The base salary range listed above is a good faith determination of potential base compensation at the time of this job advertisement and may be modified in the future.
Nominations are greatly appreciated and may be sent to:
Rachael Burns, Vice President
Ellen Lockhart, MD, Principal
Heather Van Hecke, Consultant
Physician and Leadership Solutions - Executive Search
AMN Healthcare
#BESRecruitment
#LI-HV3
Facility Location
Nestled on the banks of Lake Erie and at the southern end of the Niagara River, Buffalo is New York's second largest city right behind the Big Apple. Cultures blend in this waterfront city known for its culinary delights and friendly inhabitants who welcome newcomers with open arms. Discover the unique urban and historical neighborhoods that add to the city's charm and character, or spend some time relaxing at one of the 20 parks found around town.
Job Benefits
About the Company
At AMN Healthcare, we strive to be recognized as the most trusted, innovative, and influential force in helping healthcare organizations provide quality patient care that continually evolves to make healthcare more human, more effective, and more achievable.
Quality, Quality Services, Performance Improvement, Performance Management, Clinical Effectiveness, Accreditation, Outcomes Management, Regulatory Compliance
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
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!
Pay Transparency:
The expected pre-tax pay for this position is
$86,000.00 - $138,000.00Actual 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.
