QA Leader, Medical Devices & Combination Products (Hybrid)

Scorpion Therapeutics; Michigan; Hybrid; 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

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