Senior Quality Engineer

Insight Global is seeking a Senior Quality Engineer to support a leading medical device manufacturer specializing in combination medical devices. This newly created role is focused on establishing a best‑in‑class approach to drug–device combination products, integrating pharmaceutical science, quality systems, and manufacturing execution. The ideal candidate will have a science‑based background—such as pharmaceutical, chemistry, or combination product experience—and the ability to apply those principles within a medical device manufacturing environment.
This role provides quality and process engineering support to product development teams within Urology and Cardiology, with responsibility for reducing manufacturing defects by leading root cause analysis and implementing effective corrective and preventive actions. You will develop and maintain product and process quality documentation, including specifications, risk assessments, and FMEAs, while establishing process monitoring systems to reduce variation and eliminate defect sources. The role also involves analyzing manufacturing quality data to drive continuous improvement, creating quality tools and training materials, and ensuring compliance with regulatory and company requirements. As the technical lead for combination products under 21 CFR Part 4, you will support audits, perform trend analysis, oversee corrective actions, and approve final process monitor releases prior to distribution.
This position is fully onsite in Arden Hills, MN, and offers a salary range of $100,000–$125,000 plus a 10% bonus, depending on experience.

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- Bachelor's degree in Chemical Engineering, Chemistry or related
- 5+ years of relevant manufacturing/ quality experience
- Background in regulated industry/ pharmaceuticals
- Knowledge and ability to use statistical methods such as trend analysis, pareto and other charting techniques
- Drug combination medical device experience

- 7+ years of experience
- Experience managing multiple projects
- Audit experience as a technical lead
- Experience in 21 CFR Part 4, cGMP compliance for drug combination medical devices

Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.