Global Medical Device QA Lead - Design Controls

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

Benefits offered by this job

Relocation support

Hybrid work arrangement

Job summary

Pfizer, a global leader in healthcare, seeks a Manager of Medical Device Quality Assurance to oversee multiple concurrent MDCP programs, ensuring design controls, risk management, and lifecycle activities across 50+ markets. This role emphasizes regulatory readiness and product quality in a highly regulated environment.

You will partner with cross-functional teams to drive compliant decisions, investigate complex issues, and translate evolving international requirements into unified quality

Qualifications

• Bachelor’s degree required with relevant QA/GMP/medical device experience.
• Experience with quality activities in medical devices, combination products, or pharmaceuticals.
• Knowledge of design controls, risk management, and quality systems for medical devices.

Responsibilities

• Provide global QA oversight for MDCP programs and ensure regulatory compliance across markets.
• Guide design controls, risk management, post-approval changes, and product changes across multiple programs.
• Identify and implement process improvements to strengthen quality system maturity and product quality.

Skills

Quality Assurance

GMP manufacturing

Regulatory knowledge

Change control

Analytical skills

Communication

Education

Bachelor's degree

Tools

Quality documentation systems

CAPA systems

Regulatory databases

Job description

Pfizer, a global leader in healthcare, seeks a Manager of Medical Device Quality Assurance to oversee multiple concurrent MDCP programs, ensuring design controls, risk management, and lifecycle activities across 50+ markets. This role emphasizes regulatory readiness and product quality in a highly regulated environment.

You will partner with cross-functional teams to drive compliant decisions, investigate complex issues, and translate evolving international requirements into unified quality