Medical Device & Combination Product QA Leader

Pfizer; St. Louis (MO); Hybrid; USD 99,000 - 165,000; Full time

Benefits offered by this job

401(k) with Pfizer matching

Pfizer retirement savings contribution

Paid vacation, holidays, and personal/

Paid caregiver/parental leave

Medical, dental, and vision benefits

Job summary

Pfizer seeks a Manager, Medical Device Quality Assurance to lead quality oversight for MDCP programs across development and sustaining lifecycle. You will guide risk-based decisions, ensure design controls and quality systems compliance, and review device investigations with rigor.

The role involves cross-functional collaboration across teams, handling post-market changes, and maintaining regulatory readiness in a fast-paced environment.

Qualifications

• Bachelor's degree with 4+ years of experience; or Master's with 2+ years; or PhD with 0+ years; or Associate's with 8+ years; or high school with 10+ years in QA/GMP or medical devices.

Responsibilities

• Provide strategic and technical quality oversight across development and sustaining lifecycle.
• Review and approve device complaint investigations with technical rigor.
• Guide risk-based decision-making and ensure compliance with design control and quality system requirements.
• Support post-approval changes, supplier/component changes, and manufacturing transfers.
• Collaborate across functions to resolve issues and strengthen processes.

Skills

Quality assurance

Regulatory knowledge

Cross-functional collaboration

Risk-based decision making

Communication

Analytical skills

Education

Bachelor's degree

Master's degree

PhD

Associate's degree

High school diploma with 10+ years experience

Tools

Design controls

Risk management

Quality systems

CAPA processes

Job description

Pfizer seeks a Manager, Medical Device Quality Assurance to lead quality oversight for MDCP programs across development and sustaining lifecycle. You will guide risk-based decisions, ensure design controls and quality systems compliance, and review device investigations with rigor.

The role involves cross-functional collaboration across teams, handling post-market changes, and maintaining regulatory readiness in a fast-paced environment.