Quality Assurance Manager, Medical Device & Combination Products

Role: Medical Device Quality Assurance Manager within Pfizer’s MDCP Quality Operations, supporting development, sustaining, and complaint management of combination products. Core responsibilities include providing technical oversight on design controls, risk management, and quality systems; reviewing complaint investigations; supporting post-market changes and surveillance; and ensuring compliance with 21 CFR 820, ISO 13485, and ISO 14971. The role requires collaborating across functions to resolve complex issues, improve processes, and align quality practices, with a focus on product safety and regulatory readiness. Qualifications: Bachelor's degree with ≥4 years, or advanced degrees with fewer years, in Quality Assurance, GMP, or regulated environments supporting medical devices or combination products. Strong knowledge of design controls, risk management, and lifecycle activities is essential, alongside experience in post-market activities, supplier management, and technical validation. Preferred skills include experience in both device and pharma regulatory frameworks, including 21 CFR Part 4, and partnering with external manufacturers. The position involves frequent travel across Pfizer sites and vendors, with a hybrid work setup. High-value specifics include combination product lifecycle management, post-market surveillance, complaint investigations, and risk-based decision-making in a highly regulated setting.