Quality Assurance Manager, Medical Device & Combination Products

Pfizer; Michigan; On-site; USD 120,000 - 160,000; Full time

Job summary

Pfizer is seeking a Medical Device Quality Assurance Manager within MDCP Quality Operations to oversee design control, risk management, and lifecycle activities for combination products. This role supports development, post-market surveillance, and complaint handling with a focus on patient safety and regulatory compliance.

The ideal candidate has a strong background in regulated medical device quality systems, cross-functional collaboration, and decision-making under 21 CFR 820, ISO 13485, and

Qualifications

• Bachelor's degree with ≥4 years in regulated industries (medical device, pharma, or combination products).
• Knowledge of design controls, risk management, and quality systems.
• Strong cross-functional communication and decision-making skills.

Responsibilities

• Provide strategic quality oversight across design control, risk management, vendor management, and post-market activities.
• Review and approve complaint investigations.
• Guide risk-based decision-making.
• Monitor regulatory changes.
• Enhance quality processes.
• Ensure compliance with 21 CFR 820, ISO 13485, ISO 14971.
• Collaborate across functions to resolve issues, maintain regulatory readiness, and support product safety.

Skills

Design Controls

Risk Management

Quality Systems

Cross-functional Communication

Decision Making

Education

Bachelor's degree

Job description

Role

Medical Device Quality Assurance Manager within Pfizer's MDCP Quality Operations, supporting development, lifecycle maintenance, and complaint handling for combination products.

Responsibilities

• provide strategic quality oversight across design control, risk management, vendor management, and post-market activities
• review and approve complaint investigations
• guide risk-based decision-making
• monitor regulatory changes
• enhance quality processes
• ensure compliance with 21 CFR 820, ISO 13485, ISO 14971
• collaborate across functions to resolve issues, maintain regulatory readiness, and support product safety.

Requirements

• Bachelor's degree with ≥4 years (or advanced degrees with fewer years), experience in regulated industries (medical device, pharma, or combination products), knowledge of design controls, risk management, and quality systems
• strong cross-functional communication and decision-making skills.

Preferred

• experience with both medical device and pharmaceutical quality, lifecycle design controls, post-market surveillance, and combination product regulations (21 CFR Part 4)
• experience with supplier collaboration and technical validation.

Work setup

hybrid with frequent travel across Pfizer manufacturing sites and suppliers in the U.S. The role emphasizes technical expertise in design, risk, and lifecycle management, with a focus on compliant, patient-focused product quality.