Lab Service Quality Engineer



 We are the people who give possibilities purpose 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 Responsibilities: 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) Knowledge and Skills: 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