Senior QA Manager, Medical Devices & Combination Products

Pfizer; Andover (MA); Hybrid; USD 99,000 - 165,000; Full time

Benefits offered by this job

401(k) with Pfizer match

Paid vacation & holidays

Parental leave

Health, dental, vision insurance

Job summary

Pfizer is seeking a Manager, Medical Device Quality Assurance to oversee quality activities across lifecycle, ensuring design controls, risk management, and regulatory compliance for medical devices and combination products.

The role involves collaborating across departments, guiding investigations, and supporting post-market changes with a focus on patient safety and regulatory readiness. Hybrid work arrangement offered.

Qualifications

• Bachelor's degree or higher with required experience in Quality Assurance or regulatory environment.
• Experience with design controls, risk management and quality systems in medical devices or pharmaceutical spaces.
• Ability to work across cross-functional teams and make risk-based decisions.

Responsibilities

• Provide strategic and technical quality oversight across product lifecycle.
• Support development, sustaining and complaint investigations to ensure regulatory readiness.

Skills

Quality Assurance

Regulatory knowledge

Design controls

Risk management

Cross-functional teamwork

Communication skills

Analytical thinking

Education

Bachelor's degree

Master's degree

PhD

Associate's degree

High school diploma

Job description

Pfizer is seeking a Manager, Medical Device Quality Assurance to oversee quality activities across lifecycle, ensuring design controls, risk management, and regulatory compliance for medical devices and combination products.

The role involves collaborating across departments, guiding investigations, and supporting post-market changes with a focus on patient safety and regulatory readiness. Hybrid work arrangement offered.