Serve as a key quality partner supporting development, sustaining, and complaint activities across the product lifecycle.
Ensure 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.
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.
Work across functions to resolve issues, strengthen processes, and support product quality, patient safety, and regulatory readiness.
Provide quality oversight for MDCP programs across both development and sustaining lifecycle activities.
Assess the quality, safety, and regulatory impact of product and process changes to help ensure continued compliance and maintenance of design and risk management documentation.
Review and approve device complaint investigations with a focus on technical rigor, documentation quality, and timely closure.
Monitor changes in global regulations and help translate evolving requirements into effective policies, procedures, and quality system practices.
Identify and drive opportunities to strengthen processes, improve consistency, and advance quality system maturity across the MDCP development and sustaining space.

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.

401(k) plan with Pfizer Matching Contributions
Additional Pfizer Retirement Savings Contribution
Paid vacation
Holiday and personal days
Paid caregiver/parental and medical leave
Health benefits including medical, prescription drug, dental and vision coverage

Quality Assurance Manager – Medical Device, Combination Products

Key skills