Quality Engineer – Medical Devices

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