Senior Quality Engineer/Quality Assurance Engineer
On-site · Eden Prairie, Minnesota, United States
Job Summary
Senior Quality Engineer role at a global regenerative medicine CDMO. Lead and supervise the QA Engineering team, drive validation, risk management, nonconformance investigations, change management, and continuous improvement. Coordinate cross-functional efforts for manufacturing process improvements, support regulatory submissions and product launches, review quality KPI data, and mentor junior engineers. Hands-on experience with test method validation, sampling plans, and validation layouts across multiple TMV types; familiarity with Class II/III medical devices and design-to-manufacturing transfers.
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