Quality Assurance Manager, Medical Device & Combination Products

USE YOUR POWER FOR PURPOSE Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients. WHAT YOU WILL ACHIEVE This role is a strategic pillar within Pfizer’s Medical Device and Combination Products (MDCP) Quality Operations global team. Serving as a key global quality partner, you will champion and govern development, sustaining, and post-market activities for MDCP portfolios distributed across 50+ worldwide markets. The Manager of Medical Device Quality Assurance supports the global quality blueprint, ensuring that MDCP delivery systems are developed and sustained in strict compliance with a diverse array of international regulatory standards including ISO 13485, ISO 14971, EU MDR, 21 CFR Part 4, and FDA 21 CFR 820. You will provide strategic and technical quality oversight for design control and risk management for complex programs and guide teams using risk-based decision-making helping ensure compliance with applicable design control and quality system requirements. You will work across functions to resolve issues, strengthen processes, and support product quality, patient safety, and regulatory readiness. HOW YOU WILL ACHIEVE IT • Lead global quality assurance oversight for multiple concurrent global MDCP programs and next-generation delivery platforms, enabling the successful global launch and market sustainability of high-priority assets. • Serve as a MDCP quality partnerfor global cross-functional teams, providing authoritative, risk-based guidance on design controls, post-approval changes, supplier/component changes, manufacturing transfers, periodic product reviews, post-market surveillance, product remediations, and obsolescence planning. • Drive the resolution of complex, multi-regional business-critical quality and compliance issues, providing sound recommendations that enable practical, compliant decisions across diverse international markets and fast-paced regulatory environments. • Actively monitor shifting international regulations (e.g., EU MDR, TGA, ANVISA, NMPA, FDA) and translate evolving requirements into unified global policies, procedures, and quality system practices. • Evaluate investigation content for completeness, scientific rationale, issue linkage, risk alignment, and potential CAPA relevance. • Partner with teams to resolve complex quality issues, provide sound recommendations, and enable practical, compliant decisions in a fast-paced and highly regulated environment. • Identify and drive opportunities to strengthen processes, improve consistency, and advance quality system maturity across the MDCP development and sustaining space. • Promote alignment in the interpretation and application of quality policies and procedures across teams and activities. • Apply technical expertise across later-phase product lifecycle activities, including verification, validation, process validation, stability-related considerations, and sustaining lifecycle management of marketed products. HERE IS WHAT YOU NEED (Minimum Requirements) • Applicant must have a bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR an associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience, working in Quality Assurance, GMP manufacturing environment, pharmaceutical environment, or medical device space. • Experience supporting q