Global Medical Device Quality Assurance Lead (Hybrid)

Pfizer; St. Louis (MO); Híbrido; USD 99.000 - 165.000; Tempo integral

Benefícios oferecidos por esta vaga

401(k) with Pfizer Matching

Health benefits

Paid time off

Relocation assistance

Resumo da vaga

Pfizer is seeking a Manager of Medical Device Quality Assurance within its MDCP Quality Operations. You will lead global quality oversight for MDCP programs, govern design controls, risk management, and regulatory readiness across 50+ markets. The role requires aligning with EU MDR, 21 CFR, and FDA standards to ensure patient safety and product quality.

The position is hybrid with relocation support, offering a base salary with bonus potential and comprehensive Pfizer benefits.

Qualificações

• Minimum 4 years of experience in Quality Assurance, GMP manufacturing, or medical devices.
• Experience with design controls and risk management.

Responsabilidades

• Provide strategic quality oversight for MDCP programs across global markets.
• Lead and govern design controls and risk management activities.
• Resolve complex quality and regulatory issues across cross-functional teams.
• Monitor international regulations and translate into policies and practices.
• Evaluate investigations for completeness and risk relevance.
• Drive process improvements to strengthen quality system maturity.
• Support lifecycle management of marketed products.

Conhecimentos

Quality Assurance

Regulatory Compliance

Design Controls

Risk Management

Cross-functional Collaboration

Quality Systems

Formação

Bachelor's degree

Master's degree

PhD

Associate degree

High school diploma

Descrição da vaga

Pfizer is seeking a Manager of Medical Device Quality Assurance within its MDCP Quality Operations. You will lead global quality oversight for MDCP programs, govern design controls, risk management, and regulatory readiness across 50+ markets. The role requires aligning with EU MDR, 21 CFR, and FDA standards to ensure patient safety and product quality.

The position is hybrid with relocation support, offering a base salary with bonus potential and comprehensive Pfizer benefits.