Quality Assurance Sr. Associate, Medical Device & Combination Products

Pfizer • St Louis, MO

3d • Hybrid

About The Position

This role is part of Pfizer’s Medical Device and Combination Products (MDCP) Quality Operations team. This is a unique opportunity to contribute across both laboratory quality oversight and device complaint investigations in a complex and highly collaborative environment. As a Senior Associate in Quality Assurance, you will provide laboratory quality oversight and independent complaint investigation review for Medical Device and Combination Products (MDCPs) within Pfizer’s Quality Operations. You will help strengthen investigation quality, improve risk visibility, and support compliance for both development and commercial products. Your work will directly influence product quality, patient safety, and inspection readiness.

Requirements

• Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience.
• Experience working in Quality Assurance, GMP manufacturing environment, pharmaceutical environment, laboratory, or medical device space.
• Experience supporting or reviewing investigations in a regulated environment.
• Knowledge of root cause analysis, technical problem solving, and risk-based decision-making.
• Ability to work effectively across functions and manage ambiguity with sound judgment.
• Strong communication, collaboration, and documentation skills.
• Permanent work authorization in the United States.

Nice To Haves

• Experience with medical device or combination product complaint investigations.
• Familiarity with ISO 13485, ISO 14971, 21 CFR 820, and 21 CFR 4.
• Experience in laboratory quality oversight, test method validation/transfer, equipment qualification, or design verification testing.
• Familiarity with MDCP products including injection pens, prefilled syringes, combination product kits (e.g., syringes, needles, vials, adaptors), and Class I medical devices.
• Experience working in fast-paced, high-volume, and technically complex environments.

Responsibilities

• Provide Quality Assurance oversight of MDCP laboratory operations, including review and approval of test records, investigations, and change controls.
• Support root cause investigations related to laboratory testing, design verification and validation, manufacturing, and device functionality.
• Support audit and inspection readiness for both internal and external audits.
• Contribute to ongoing compliance with applicable regulatory and quality system requirements including 21 CFR 820, ISO 13485, and ISO 14971.
• Review and approve device complaint investigations with a focus on technical rigor, documentation quality, and timely closure.
• Evaluate investigation content for completeness, scientific rationale, issue linkage, risk alignment, and potential CAPA relevance.
• Partner with cross-functional teams and subject matter experts to resolve complex quality issues and improve investigation effectiveness.

Benefits

• 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 to include medical, prescription drug, dental and vision coverage
• Relocation assistance may be available

What This Job Offers

• Job Type: Full-time
• Career Level: Senior