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
