Quality Assurance Manager, Medical Device & Combination Products

Role: Medical Device Quality Assurance Manager supporting development and lifecycle activities for combination products at Pfizer. Responsibilities: provide quality oversight for design controls, risk management, complaint investigations, post-market surveillance, and manufacturing transfers; guide cross-functional teams on compliance with 21 CFR 820, ISO 13485, and ISO 14971; evaluate product and process changes, approve investigations, and support regulatory readiness. Requirements: bachelor's degree with 4+ years or master's with 2+ years of experience in QA within regulated environments; knowledge of design controls, risk management, and GxP standards; experience supporting product development and post-market activities. Preferred: experience in both medical devices and pharmaceuticals, especially combination products; familiarity with regulation (e.g., 21 CFR Part 4); experience with verification, validation, and supplier management. Work setup: hybrid work environment with frequent travel to manufacturing sites and vendors; focus on product safety, compliance, and process improvement across development and sustaining phases.