Quality Assurance Sr. Associate, 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.

WHAT YOU WILL ACHIEVE

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.

HOW YOU WILL ACHIEVE IT

• 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.

HERE IS WHAT YOU NEED (Minimum 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.

BONUS POINTS IF YOU HAVE (Preferred Requirements)

• 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.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Supports a high-volume complaint investigation environment serving global medical device and combination product portfolios, requiring interaction with both internal teams and external manufacturing partners.

  

OTHER JOB DETAILS

Work Location Assignment: Hybrid

Last Date to Apply for Job: June 25, 2026

The annual base salary for this position ranges from $82,700.00 to $137,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 10.0% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision c