Lab Service Quality Engineer
BD
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Benefits offered by this job
Job summary
BD is a leading global medical technology company. This role focuses on leading design verification testing for combination products, ensuring compliance with FDA, ISO, and GMP standards, and driving continuous quality improvements across laboratories and manufacturing environments.
The position emphasizes collaboration with Technology Development, Operations, Quality, and Business Development teams, mentoring engineers, and acting as QA representative during audits and inspections.
Qualifications
- Bachelor’s degree in engineering, Biomedical Sciences, or related field with 7 years of experience in quality engineering or related field OR
- Master’s degree in engineering, Biomedical Sciences, or related field with 5 years of experience in quality engineering or related field
- Experience with mechanical and analytical testing of drug-device combination products.
Responsibilities
- Lead and execute design verification testing for combination products per FDA 21 CFR Parts 210, 211, 820 and ISO 13485.
- Develop, review, and approve test protocols, methods, and reports ensuring alignment with design control, risk management, and regulatory needs.
- Partner with cross-functional teams to drive project execution and delivery.
- Ensure laboratory operations comply with GLP and GMP standards.
- Lead root cause investigations, CAPAs, deviations, nonconformances, and OOS/OOT events.
Skills
Education
Tools
Job description
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
Job Description
- Lead and execute design verification testing for combination products in compliance with FDA 21 CFR Parts 210, 211, and 820, ISO/IEC 17025, and ISO 13485.
- Develop, review, and approve test protocols, methods, and reports to ensure alignment with design control, risk management, and regulatory requirements.
- Partner with Technology Development, Operations, Quality, and Business Development teams to drive successful project execution and delivery.
- Ensure laboratory operations comply with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) standards.
- Lead and support root cause investigations, CAPAs, deviations, nonconformances, and OOS/OOT events, driving effective resolution and continuous improvement.
- Provide technical leadership, mentorship, and training to engineers, laboratory personnel, and operations teams.
- Act as a key Quality Assurance representative during internal audits, customer audits, and regulatory inspections.
- Maintain and enhance Quality Management System (QMS) processes, including CAPA, nonconformance management, calibration and maintenance programs, equipment qualification, and document control.
- Conduct thorough reviews of project documentation, including protocols, laboratory data, audit trails, validation records, and final reports prior to client release.
- Support the development, validation, and continual improvement of test methods and testing protocols, providing quality expertise throughout the process.
- Identify opportunities to strengthen quality systems, improve compliance, and streamline operational processes.
- Analyze quality and manufacturing data, including nonconformances, CAPAs, deviations, OOS, and OOT events, to identify trends and drive continuous improvement initiatives.
- Develop and present quality metrics, KPI performance, and compliance reports to senior leadership.
- Stay current on evolving regulatory requirements and industry expectations for combination products and quality systems.
- Support the integration of the ZebraSci Quality Management System into BD global quality procedures and systems.
- Train, coach, and guide employees on quality standards, compliance expectations, problem‑solving methodologies, and investigation processes.
- Bachelor’s degree in engineering, Biomedical Sciences, or related field and 7 years experience in quality engineering or related field OR
- Master’s degree in engineering, Biomedical Sciences, or related field and 5 years experience in quality engineering or related field
- Experience with mechanical and analytical testing of drug-device combination products.
- Experience in a combination product or medical device environment.
- Experience with executing and supporting out-of-specification investigations (OOS)
- Experience managing or participating in audits
- Experience with Laboratory Information Management Systems (LIMS)
- Strong knowledge of design control, risk management (ISO 14971), and verification/validation principles.
- Familiarity with 21 CFR Part 820, 21 CFR Part 4, and ISO 13485.
- Proficiency in statistical analysis tools and quality engineering methodologies (e.g., Gage R&R, DOE, FMEA).
- Technical writing knowledge and skill.
- Ability to author Quality System documentation, reports including review of data and data analysis.
- Demonstrated knowledge and experience in executing CAPA, with knowledge of investigation tools, problem solving process and methodology
- Knowledge and understanding of risk management principles and application to the management of quality and decision‑making process
- Excellent communication skills and level of comfort to communicate internally at all levels of the organization and with customers /regulators.
At BD, we prioritize on‑site collaboration because we believe it fosters creativity, innovation, and effective problem‑solving, which are essential in the fast‑paced healthcare industry. For most roles, we require a minimum of 4 days of in‑office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work‑life balance. Remote or field‑based positions will have different workplace arrangements which will be indicated in the job posting.
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID‑19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
At BD, we are committed to supporting our associates’ well‑being, development, and success through a performance‑based culture. For this position, BD offers a competitive compensation package along with the following benefits specific to this role:
- Annual Bonus
- Potential Discretionary LTI Bonus
- Medical coverage
- Health Savings Accounts
- Flexible Spending Accounts
- Dental coverage
- Vision coverage
- Hospital Care Insurance
- Critical Illness Insurance
- Accidental Injury Insurance
- Life and AD&D insurance
- Short‑term disability coverage
- Long‑term disability insurance
- Long‑term care with life insurance
- Anxiety management program
- Wellness incentives
- Sleep improvement program
- Diabetes management program
- Virtual physical therapy
- Emotional/mental health support programs
- Weight management programs
- Gastrointestinal health program
- Substance use management program
- Musculoskeletal surgery, cancer treatment, and bariatric surgery benefit
- BD 401(k) Plan
- BD Deferred Compensation and Restoration Plan
- 529 College Savings Plan
- Financial counseling
- Baxter Credit Union (BCU)
- Daily Pay
- College financial aid and application guidance
- Paid time off (PTO), including all required State leaves
- Educational assistance/tuition reimbursement
- MetLife Legal Plan
- Group auto and home insurance
- Pet insurance
- Commuter benefits
- Discounts on products and services
- Academic Achievement Scholarship
- Service Recognition Awards
- Employer matching donation
- Workplace accommodations
- Adoption assistance
- Backup day care and eldercare
- Support for neurodivergent adults, children, and caregivers
- Caregiving assistance for elderly and special needs individuals
- Employee Assistance Program (EAP)
- Paid Parental Leave
- Support for fertility, birthing, postpartum, and age‑related hormonal changes
- Bereavement leaves
- Military leave
- Personal leave
- Family and Medical Leave (FML)
- Jury and Witness Duty Leave
87,200.00 - 139,500.00 USD Annual
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face‑to‑face collaboration supports your learning, your progress, and your success.
To learn more about BD visit https://bd.com/careers.
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.
USA NJ Branchburg
At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance‑based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."
$87,200.00 - $139,500.00 USD Annual
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