Quality Assurance Manager, Medical Device & Combination Products

Pfizer; Missouri; Sur place; USD 110 000 - 160 000; Plein temps

Avantages offerts par ce poste

Hybrid work arrangement

Résumé du poste

Pfizer’s MDCP Quality Operations seeks a Medical Device Quality Assurance Manager to oversee development, sustaining activities, and complaint investigations for combination products in compliance with design controls and regulatory standards (21 CFR 820, ISO 13485, ISO 14971).

Hybrid work arrangement with frequent travel across manufacturing sites and vendors; role emphasizes risk-based decision-making and continuous process improvement through cross-functional leadership.

Qualifications

• Bachelor’s degree with 4+ years in regulated medical device or pharmaceutical QA.

Responsabilités

• Provide strategic quality oversight across product lifecycle stages and support post-market activities.
• Review investigations, assess change impacts, and guide risk-based decision-making; collaborate cross-functionally to resolve issues and improve processes.

Connaissances

Strong communication

Problem-solving

Cross-functional collaboration

Formation

Bachelor's degree

Description du poste

Role

Medical Device Quality Assurance Manager within Pfizer’s MDCP Quality Operations, overseeing development, sustaining activities, and complaint investigations for combination products in compliance with design control and regulatory standards (21 CFR 820, ISO 13485, ISO 14971).

Responsibilities

provide strategic quality oversight across product lifecycle stages, support post-market activities, review investigations, assess change impacts, and guide risk-based decision-making; collaborate cross-functionally to resolve issues and improve processes; monitor regulatory changes and ensure compliance.

Requirements

bachelor’s degree with 4+ years or equivalent experience supporting regulated medical device or pharmaceutical quality activities, with knowledge of design controls, risk management, and quality systems.

Preferred

experience with combination products, regulatory requirements (21 CFR Part 4), lifecycle management, post-market surveillance, and working with suppliers.

Skills

strong communication, problem-solving, and cross-functional collaboration abilities.

Work

hybrid location; frequent travel across manufacturing sites and vendors.