QA Manager, Medical Devices & Combination Products (Hybrid)

Pfizer; Saint Louis (MI); Hybrid; USD 99,000 - 165,000; Full time

Job summary

Pfizer is seeking a Quality Assurance Manager for Medical Device & Combination Products in a hybrid role based in the United States. You will provide strategic quality oversight across development and sustaining lifecycles, guiding risk-based decisions and ensuring design controls and quality systems compliance.

The role requires strong collaboration across functions, handling post-market activities, supplier changes, and regulatory readiness to protect patient safety and product quality.

Qualifications

• Bachelor's degree with 4+ years QA/regulated industry experience.
• Master's degree with 2+ years experience.
• PhD with 0+ years experience.
• Associate's degree with 8 years experience.
• High school diploma with 10 years relevant QA experience.

Responsibilities

• Provide quality oversight for MDCP programs across development and sustaining lifecycle.
• Serve as a key quality partner for cross-functional teams; provide risk-based guidance on design controls, risk management, and quality systems.
• Review and approve device complaint investigations with technical rigor and timely closure.
• Monitor regulatory changes and translate requirements into policies and practices.
• Identify opportunities to strengthen processes and advance quality system maturity.

Skills

Quality Assurance

Design controls

Risk management

Cross-functional

Education

Bachelor's degree

Job description

Pfizer is seeking a Quality Assurance Manager for Medical Device & Combination Products in a hybrid role based in the United States. You will provide strategic quality oversight across development and sustaining lifecycles, guiding risk-based decisions and ensuring design controls and quality systems compliance.

The role requires strong collaboration across functions, handling post-market activities, supplier changes, and regulatory readiness to protect patient safety and product quality.