Quality Assurance Manager, Medical Device & Combination Products

Role: Medical Device Quality Assurance Manager within Pfizer’s MDCP Quality Operations, supporting development, lifecycle maintenance, and complaint handling for combination products. Responsibilities: provide strategic quality oversight across design control, risk management, vendor management, and post-market activities; review and approve complaint investigations; guide risk-based decision-making; monitor regulatory changes; enhance quality processes; ensure compliance with 21 CFR 820, ISO 13485, ISO 14971; collaborate across functions to resolve issues, maintain regulatory readiness, and support product safety. Requirements: Bachelor's degree with ≥4 years (or advanced degrees with fewer years), experience in regulated industries (medical device, pharma, or combination products), knowledge of design controls, risk management, and quality systems; strong cross-functional communication and decision-making skills. Preferred: experience with both medical device and pharmaceutical quality, lifecycle design controls, post-market surveillance, and combination product regulations (21 CFR Part 4); experience with supplier collaboration and technical validation. Work setup: hybrid with frequent travel across Pfizer manufacturing sites and suppliers in the U.S. The role emphasizes technical expertise in design, risk, and lifecycle management, with a focus on compliant, patient-focused product quality.