Quality Operations Manager

Medasource; Madison (WI); On-site; USD 150,000 - 190,000; Full time

Job summary

Medasource is hiring an Operations Quality Manager to lead the operations quality team—Supplier Quality Engineers, Manufacturing Quality Engineers, and Quality Technicians—and own all quality activities related to procurement and production of saleable product. This is a working manager role, blending leadership with hands-on engineering.

In addition to setting team goals and developing members, the role will personally perform hands-on quality engineering tasks as needed to support workload and

Qualifications

• Bachelor's degree in Engineering or related technical field required.
• 10+ years in medical device manufacturing with people-management experience.
• Demonstrated leadership of supplier/manufacturing quality functions.
• Working knowledge of ISO 13485, 21 CFR 820, and EU MDR requirements.

Responsibilities

• Lead the Operations Quality team, setting goals, managing performance, and developing team members.
• Personally perform hands-on quality engineering and inspection work as needed.
• Own all quality activities related to 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.

Skills

Leadership

People management

Quality engineering

Regulatory compliance

Auditing

Education

Bachelor's in Engineering or related field

Tools

ERP systems

eQMS ComplianceQuest

Quality management software

Job description

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).


• 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.