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

• Bachelors 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