Overview
Quality Engineer – Medical Devices Jobs in Minneapolis, MN at Stark Pharma
Title: Quality Engineer – Medical Devices
Company: Stark Pharma
Location: Minneapolis, MN
Job Title: Quality Assurance Engineer Medical Devices
Location: Northwest Minneapolis Metro Area
Type: 6-Month Contract-to-Hire
Job Summary
Seeking a Quality Assurance Engineer to support quality systems, manufacturing operations, CAPA, validation, audits, and DHF activities within a medical device environment. This role will partner cross-functionally to ensure compliance with FDA and ISO standards throughout the product lifecycle.
Key Responsibilities
- Manage CAPAs, nonconformances, root cause investigations, and change controls
- Support IQ/OQ/PQ validation activities and review quality documentation
- Maintain DHF documentation and support product lifecycle activities
- Review batch records, work orders, and manufacturing documentation for GMP compliance
- Support incoming inspection, supplier quality, and audit readiness
- Analyze quality metrics and drive continuous improvement initiatives
- Support customer complaint investigations and PLM system updates
Required Qualifications
- Bachelor s degree in Engineering, Life Sciences, or related field
- 5+ years of medical device quality or design assurance experience
- Strong knowledge of FDA 21 CFR 820, ISO 13485, and ISO 14971
- Experience with CAPA, NCs, DHF, audits, and validation activities
- Familiarity with PLM systems such as Windchill, Agile, or Propel
