Job Description Summary
The Senior Quality Engineer is responsible for supporting Design Quality Assurance within the Infection Prevention Platform: Design Controls, Risk Management, Human Factors / Usability Engineering. The incumbent works multi-functionally with teams on new product design, design transfer, risk management, process/product design, quality improvement projects (QIPs) and cost to win (CTW) projects.
Job Description
We are the makers of possible
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.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.
General Functions, Specific Responsibilities, and Authority:
The Senior Quality Engineer works closely with shared functions (e.g. Regulatory Affairs, Designated Complaint Handling Unit (DCHU), Sterility Assurance, etc.), as well as R&D, Manufacturing, Sales, Marketing, Operations, and Finance. The Senior Quality Engineer interacts with Regulatory Affairs regarding new regulations and standards as they apply to new product development regulatory submissions and regional expansions, with DCHU on complaint handling/resolution and field actions pre-/post - product launch, Packaging COE on new product packaging projects and changes, Sterility Assurance on sterilization process (re)validations and with Platform Management regarding product design and development, as well as design transfer activities.
Product Development:
• Provide Technical guidance to Quality Engineers, Quality Technicians, and Inspectors.
• Support Pre-Concept Front End Product Innovation Process activities for new technologies.
• Lead Quality Engineering Projects to improve Quality systems and Procedures.
• Develop and maintain product Design History File (DHF) & Drug Master File (DMF).
• Development of the Risk Management File in accordance with ISO14971, coordinating input from the other Design Sub-team members including the development of the design, process, and usability FMEAs.
• Development of Design Verification Protocols and subsequent Design Verification Reports including analysis of all data and decisions on design acceptability.
• Development of Design Validation Protocols and subsequent Design Validation Reports including an analysis of all data and a decision on design acceptability.
• Provide input into the project Design Inputs, Design Outputs, Product Specifications, Product Development Plan, and applicable design control documents as defined per BD’s product development process and 21CFR 820.
• Development of Test Protocols and Final Report to support Regulatory 510K, PMA, (A)NDA, CE mark and International registrations.
• Determine the degree of Biocompatibility testing required for product changes and new product development efforts as per ISO10993 and company procedures working with BD COEs.
• Develop or assist in development of inspection and test methods per product specifications.
• Develop test protocols and release a final report on Shelf Life and Stability Studies in support of expiration dating.
• Perform test method validations to ensure accuracy, precision, selectivity, sensitivity, stability, and reproducibility of analytical or physical test methods used to assess the safety and efficacy of devices.
• Develop shelf life and stability test protocols and reports as required.
Process Development:
• Develop and document the Control System for the manufacture of new products including Inspection Plans for the inspection of components, sub-assemblies and final product.
• Support the development of manufacturing control plans for internal and outsourced processes.
• Support (or lead) development of the PFMEA.
• Perform and/or Support Process Development Studies to determine the acceptability of new processes or equipment.
• Design and qualify inspection test methods and equipment.
• Provide Quality Engineering Support to outsourced analytical laboratories and manufacturing facilities to ensure compliance with applicable requirements of 21CFR 820, 210, 211; cGMP’s, CMC, and ISO13485 requirements.
• Lead supplier part qualification activities including mold qualification and DOEs.
• Support Process Transfers to the Production facilities.
Other:
• Support the disposition investigation and decisions of rejected nonconforming components and products; conduct MRB action when required.
• Organize and generate detailed quality information reports to show trends and the impact of process improvements.
• Support Design / Process
Location: Warwick, RI (+1 other)
Posted: Aug. 21, 2024, 10:20 p.m.
Apply Now Company Website