Senior QA Manager, Medical Devices & Combination Products

Scorpion Therapeutics; Missouri; Hybrid; USD 110,000 - 160,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

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.

Responsibilities

• 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.

Skills

Strong communication

Problem-solving

Cross-functional collaboration

Education

Bachelor's degree

Job description

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.