We are the people who give possibilities purposeBD 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 DescriptionResponsibilities: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 opportu
