Quality Operations Manager

Position Summary

The Operation Quality Manager leads the operations quality team — Supplier Quality Engineers, Manufacturing Quality Engineers, and Quality Technicians — and owns all quality activities related to the procurement and production of saleable product.

This is a working manager role: in addition to setting team goals, managing performance, and developing team members, this role personally performs hands-on quality engineering work as needed to support team workload.

Key Responsibilities

• Lead the Operations Quality team, including Supplier Quality Engineers, Manufacturing Quality Engineers, and Quality Technicians — setting goals, managing performance, and developing team members.
• Personally perform hands-on quality engineering and inspection work as needed (e.g., supplier audits, process validation activities, nonconformance investigations, incoming/in-process/final inspection) to support team workload and maintain technical proficiency across the functions supervised.
• Own all quality activities related to the procurement and production of saleable product, ensuring compliance with 21 CFR 820, ISO 13485, and EU MDR requirements.
• Oversee the supplier qualification, SCAR, and supplier audit programs led by the Supplier Quality function.
• Oversee process validation, nonconformance management, and product release activities led by the Manufacturing Quality function.
• Oversee the incoming, in-process, and finished device inspection programs and the calibration program performed by Quality Technicians.
• Partner with Operations, Supply Chain, and Manufacturing Engineering leadership on quality risk related to procurement and production.
• Support internal and external audits (Notified Body/Registrar, FDA) related to operations quality, including hosting auditors as needed.
• Report operations-quality metrics and trends to the Head of Quality and contribute to quality system management reviews.

Required Qualifications

• Bachelor's degree in Engineering or a related technical field preferred; extensive relevant experience may substitute.
• 10+ years of experience in medical device manufacturing, including prior people-management experience.
• Demonstrated leadership of supplier quality and/or manufacturing quality functions.
• Working knowledge of ISO 13485, 21 CFR 820, and EU MDR requirements.
• Proficient with standard office software (Microsoft Office suite or equivalent).

Preferred Qualifications

• ASQ certification (CQE, CQM, or equivalent).
• ISO 13485 Lead Auditor certification.
• Experience with ERP systems and eQMS platforms, specifically ComplianceQuest.
• Experience hosting Notified Body/Registrar auditors or FDA investigators during on-site inspections.

Travel Requirements

• Less than 10%.

Work Environment & Physical Demands

• Requires the ability to sit or stand for extended periods, use a computer workstation, and occasionally lift up to 25 lbs.
• Reasonable accommodations will be made for individuals with disabilities to perform essential job functions.