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Regulatory Quality Engineer; Medical Devices

Job in Kenosha, Kenosha County, Wisconsin, 53142, USA
Listing for: ARCH
Full Time position
Listed on 2026-10-20
Job specializations:
  • Quality Assurance - QA/QC
    Quality Engineering, Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 85000 - 120000 USD Yearly USD 85000.00 120000.00 YEAR
Job Description & How to Apply Below
Position: Regulatory Quality Engineer (Medical Devices)

ARCH is seeking a Quality System Management Representative to oversee the Elmhurst, IL and Kenosha, WI facilities. You will promote awareness of applicable regulatory and QMS requirements, train personnel, and ensure QMS processes are established, implemented, and maintained.

The role requires strong knowledge of FDA 21 CFR 820, ISO 13485, and related standards, with responsibility for internal/external audits, CAPA, and supplier coordination across sites.

We would love to welcome a new Regulatory Quality Engineer (Medical Devices) to our organisation in Kenosha, WI, United States.

Our group is growing, and we are hiring a Regulatory Quality Engineer (Medical Devices) in Kenosha, WI, United States.

This opening is for the Regulatory Quality Engineer (Medical Devices) role at ARCH.

We are seeking a motivated Regulatory Quality Engineer (Medical Devices) to join ARCH in Kenosha, WI, United States.

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