Senior Quality Engineer – Quality Systems & Compliance

MGS Manufacturing; Town of Richfield (WI); On-site; USD 90,000 - 120,000; Full time

Job summary

MGS Mfg. Group in Wisconsin seeks a Senior Quality Engineer to monitor and continuously improve the Quality System Elements. You will lead QA activities, ensure GMP/GDP compliance, and support internal audits and customer-facing quality initiatives.

The role requires experience with ISO13485, FDA 21 CFR Part 820, and cleanroom operations, plus the ability to drive change, mentor staff, and collaborate across functions to deliver compliant products.

Qualifications

• High School Diploma or equivalent.
• Seven to ten years of experience and/or training, or equivalent combination of education and experience.
• QS / ISO System experience.
• Understanding/working knowledge of ISO13485 and FDA 21 CFR Part 820 and 11.
• Experience with ISO class 8 cleanroom.
• Experience in working with team, ability to drive change and influence cultural change.

Responsibilities

• Monitor and continuously improve the quality system elements.
• Perform batch record review to release products.
• Develop, review and approve validation protocols and final reports.
• Assist in deviation resolution and corrective actions.
• Lead internal audits and act as a liaison during audits.
• Review and approve engineering changes and related documentation.

Skills

QA knowledge

ISO13485 knowledge

FDA 21 CFR Part 820

GMP/GDP experience

Internal audits

Change management

Education

High School Diploma or equivalent

QS / ISO System experience

Job description

MGS Mfg. Group in Wisconsin seeks a Senior Quality Engineer to monitor and continuously improve the Quality System Elements. You will lead QA activities, ensure GMP/GDP compliance, and support internal audits and customer-facing quality initiatives.

The role requires experience with ISO13485, FDA 21 CFR Part 820, and cleanroom operations, plus the ability to drive change, mentor staff, and collaborate across functions to deliver compliant products.