Quality Assurance Manager, Medical Device & Combination Products

Role: Medical Device Quality Assurance Manager supporting development and lifecycle activities of combination products within Pfizer’s MDCP Quality Operations. Responsibilities: oversee compliance with design control, risk management, and quality system standards (21 CFR 820, ISO 13485, ISO 14971); provide technical guidance on design changes, complaint investigations, and post-market activities; partner across functions to resolve quality issues, assess product changes, and ensure regulatory readiness; monitor evolving regulations and implement process improvements. Requirements: Bachelor's degree with 4+ years or advanced degree with fewer years, experience in regulated environments (medical devices, pharmaceuticals, or combination products), and knowledge of quality standards and lifecycle management. Preferred: experience supporting on-market changes, post-market surveillance, and working with suppliers in regulatory settings; familiarity with verification, validation, and risk-based decision-making. HighValue: focus on combination products, lifecycle management, complaint handling, risk-based decision-making, global regulation updates, and cross-functional collaboration. WorkSetup: hybrid; travel required across Pfizer manufacturing sites and vendors.