Global Medical Device QA Leader

Regulatory Jobs; Chesterfield (MO); Hybrid; USD 99,000 - 165,000; Full time

Benefits offered by this job

Relocation assistance

Hybrid work model

Comprehensive benefits

Job summary

Pfizer is seeking a Manager of Medical Device Quality Assurance to lead global QA oversight for MDCP programs, ensuring design control, risk management, and regulatory readiness across 50+ markets. You will partner with cross-functional teams to resolve complex quality issues and drive process improvements.

The role emphasizes risk-based decision-making, collaboration, and ensuring product quality, patient safety, and regulatory compliance in a highly regulated environment.

Qualifications

• Bachelor's degree with at least 4 years of experience; OR a master's with at least 2 years; OR a PhD with 0+ years; OR an associate's with 8 years; OR a high school diploma with 10 years in QA, GMP, pharma or medical device.
• Experience in quality activities for medical devices, combination products, pharmaceuticals, or another highly regulated industry.
• Working knowledge of quality/regulatory requirements such as design controls, risk management, and QMS in medical devices and/or pharma.
• Experience supporting product development and sustaining lifecycle activities, including change control.
• Ability to work across cross-functional teams and make risk-based decisions in complex situations.
• Strong communication, influencing, and collaboration skills.
• Strong analytical skills and ability to work with quality documentation, systems, and data.

Responsibilities

• Provide global quality oversight for multiple MDCP programs and launches.
• Serve as quality partner for cross-functional teams with guidance on design controls and post-market changes.
• Drive resolution of complex quality and regulatory issues across regions.
• Monitor international regulations and translate requirements into global policies and practices.
• Evaluate investigations for completeness and risk relevance; identify CAPA.
• Partner with teams to drive compliant decisions in fast-paced environments.
• Identify opportunities to strengthen processes and quality system maturity across MDCP lifecycle.

Skills

Strong communication

Analytical skills

Cross-functional collaboration

Risk-based decision making

Quality documentation

Education

Bachelor's degree +4 years experience

Master's degree +2 years experience

PhD +0 years experience

Associate's degree +8 years experience

High school diploma +10 years experience

Job description

Pfizer is seeking a Manager of Medical Device Quality Assurance to lead global QA oversight for MDCP programs, ensuring design control, risk management, and regulatory readiness across 50+ markets. You will partner with cross-functional teams to resolve complex quality issues and drive process improvements.

The role emphasizes risk-based decision-making, collaboration, and ensuring product quality, patient safety, and regulatory compliance in a highly regulated environment.