Quality Assurance Manager, Medical Device & Combination Products

Medical Device Quality Assurance Manager within Pfizer's MDCP Quality Operations, supporting development, lifecycle maintenance, and complaint handling for combination products.

• 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.

• 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.

• 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.

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.