Quality Assurance Manager, Medical Device & Combination Products
Listed on 2026-10-09
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Quality Assurance - QA/QC
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Healthcare
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).
Responsibilitiesprovide 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.
Requirementsbachelor’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.
Preferredexperience with combination products, regulatory requirements (21 CFR Part
4), lifecycle management, post-market surveillance, and working with suppliers.
strong communication, problem-solving, and cross-functional collaboration abilities.
Workhybrid location; frequent travel across manufacturing sites and vendors.
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