Responsible for representing QA on cross-functional teams and executing Quality System requirements to ensure products are properly transferred from development to manufacturing and maintained on market while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide.
Products include medical devices and combination products, such as infusion pumps, enteral and sub-cutaneous tubing, Pre-filled Syringes, Autoinjectors, Eyecare Products, Aesthetic Devices, etc.
Roles & Responsibilities:
Primary driver for the quality and compliance aspects of product transfer and on-market change management.
Serves as the primary quality lead for design transfer activities to enable product launch, including transfers both within and outside of Client.
Lead/support process validation activities (IQ/OQ/PQ/PPQ),...
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