Specific duties will include: • Assisting in supporting biomanufacturing teams in the investigation of manufacturing problems and product complaints, helping them to determine the root cause of the malfunctions and recommending the appropriate corrective and preventive actions to prevent their recurrence; • Investigating and processing medical device complaints and maintaining an appropriate and manageable level of open complaints; • Assisting in maintaining quality system information databases, evaluating quality data and preparing periodic reports to monitor business trends; • Providing Quality oversight and guidance to the design and development of new products, and to support the development of viable production processes for the products under development Supporting Engineering in the development, testing, verification, validation and commercialization of new products; • Processing Non-Conforming Material Reports (NCMRs) including Material Review Board (MRB) dispositioning; Assist with nonconformance (product or process) process including immediate actions, containment, root cause investigation; corrective action and disposition of nonconforming materials during Material Review Board (MRB) meetings; • Ensure that design control requirements are being met in an effective manner to achieve quality by design, including those for design verification, validation, specification and procedure development, risk management, and design review. Must also have 3 years of experience (which can have been gained concurrently with the primary experience requirement above) working with the following: • ISO14971, 21 CFR Part 820 and ISO 13485; Investigating and processing medical device product complaints and preparation of Nonconforming Material Reports and performing Root Cause Analysis and CAPAs; • Minitab, Gage R&R and Change Control review; • Risk analysis, DFMEA, Design Verification, and test method validation as well as with procedural gap analysis; and.