Senior Quality Engineer/Design Quality Engineer

Senior Quality Engineer / Design Quality Engineer responsible for owning risk management and design quality across the full product development lifecycle for implantable electronic devices. Lead risk management end-to-end (plans, assessments, risk documentation), coordinate Design History Files, drive design control compliance, review/approve change orders, manage post-market surveillance, support internal audits, CAPA ownership, and non-conformance investigations using formal quality engineering tools. Requires background with implantable or active electronic medical devices, hands-on ISO 14971 risk management, familiarity with MDSAP and EU MDR in addition to 21 CFR Part 820, and ability to author and own design control documentation without guidance.