Quality Assurance Manager, Medical Device & Combination Products

Role: Medical Device Quality Assurance Manager within Pfizer’s MDCP Quality Operations, overseeing development, sustaining activities, and complaint investigations for combination products in compliance with design control and regulatory standards (21 CFR 820, ISO 13485, ISO 14971). Responsibilities: provide strategic quality oversight across product lifecycle stages, support post-market activities, review investigations, assess change impacts, and guide risk-based decision-making; collaborate cross-functionally to resolve issues and improve processes; monitor regulatory changes and ensure compliance. Requirements: bachelor’s degree with 4+ years or equivalent experience supporting regulated medical device or pharmaceutical quality activities, with knowledge of design controls, risk management, and quality systems. Preferred: experience with combination products, regulatory requirements (21 CFR Part 4), lifecycle management, post-market surveillance, and working with suppliers. Skills: strong communication, problem-solving, and cross-functional collaboration abilities. Work: hybrid location; frequent travel across manufacturing sites and vendors. High-value specifics include focus on combination products, lifecycle management, compliance with GxP and international standards, and supporting both development and post-market activities in a highly regulated environment.