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.

This role is part of Pfizer’s Medical Device and Combination Products (MDCP) Quality Operations team. In this role, you will serve as a key quality partner supporting development, sustaining, and complaint activities across the product lifecycle. The Manager, Medical Device Quality Assurance, is responsible for ensuring that medical devices and combination products are developed and maintained in compliance with applicable design control requirements and key regulatory standards, including 21 CFR 820, ISO 13485, and ISO 14971.

You will provide strategic and technical quality oversight for both complex programs and for complaint investigations, guide risk‑based decision‑making, and help 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.

• 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 quality activities in medical devices, combination products, pharmaceuticals, or another highly regulated industry.
• Working knowledge of applicable quality and regulatory requirements, such as design controls, risk management, and quality system requirements relevant to medical devices and/or combination products or pharmaceutical products.
• Experience supporting product development and/or sustaining lifecycle activities, including change control and ongoing product maintenance.
• Ability to work effectively across cross‑functional teams and make sound, risk‑based decisions in complex or ambiguous situations.
• Strong communication, influencing, and collaboration skills.
• Strong analytical skills and ability to work effectively with quality documentation, systems, and data.

• Experience in both medical device and pharmaceutical quality environments, especially combination products.
• Strong experience with design controls and risk management across the product lifecycle, from development through launch and post‑market sustaining.
• Experience supporting on‑market product changes, post‑approval changes, supplier or component changes, and manufacturing transfers.
• Experience with post‑market surveillance, complaint evaluation, periodic product review, and remediation activities.
• Working knowledge of combination product regulations, including 21 CFR Part 4, and broader medical device regulatory expectations.
• Experience partnering with suppliers, vendors, or external manufacturers in a regulated environment.
• Experience applying a risk‑based approach to complex quality decisions in fast‑paced, cross‑functional settings.
• Familiarity with verification, validation, process validation, usability, software, or other technical development areas relevant to medical device programs.

• The role may…