Associate Director, Device Quality Assurance - Hybrid

Job description

Job Description The Associate Director, Device Quality Assurance within Device Quality & Regulatory (DQ&R) is responsible for providing quality oversight of our Company's Device Network. This specific role is responsible for providing quality support for device assembly and packaging operations at our Company's Wilson, NC site and will be based on-site at Wilson. This role will serve as the primary interface between our Research & Development Division DQ&R and our Company's Wilson, NC site for the following aspects: 1. Serve as on-site quality oversight for medical device and combination product operations which require above-site support: Accountable for on-site Device Quality and Regulatory support for design transfer of combination products including method transfers to Wilson. Provides on-site Device Quality and Regulatory support for device assembly and packaging qualification and validation activities such as IQ/OQ/PQ and PPQ at Wilson. Accountable for coordinating Device Quality and Regulatory triage and root cause investigation of deviations impacting device assembly and packaging operations. Accountable for coordinating Device Quality and Regulatory evaluation of changes t...