Senior Quality Engineer - Quality Systems & Audit Expert

MGS Mfg. Group

Town of Richfield (WI)

On-site

USD 85,000 - 125,000

Full time

14 days+

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Job summary

MGS Mfg. Group is seeking a Senior Quality Engineer to monitor and continually improve the Quality System elements at our facility in Wisconsin. You will lead compliance with GMP/GDP, review batch records, validate protocols, and drive corrective actions.

The role requires hands-on auditing experience, ISO13485 knowledge, and the ability to mentor QA staff while supporting customer needs. Strong collaboration with cross-functional teams and a commitment to continuous quality improvement are

Qualifications

High School Diploma or equivalent required.
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.
Previous auditing experience.
Experience with ISO class 8 cleanroom.
Experience in working with team, ability to drive change and influence cultural change.

Responsibilities

Perform batch record review to release products.
Develop, review and approve validation protocols and final reports. Analyze the validation data. Assist in deviation resolution and corrective actions.
Mentor QEs in their daily tasks.
Act as a liaison between customer and MGS.
Act as subject matter experts on quality system processes.
Review and approve engineering change package.
Continuously improve the quality system.
Acts as backup for the quality manager during 2nd and 3rd party audits.