Quality Engineer – Medical Devices
Job Location:
Job Location:
Minneapolis, MN - USA
Monthly Salary:
Not Disclosed
Monthly Salary:
Posted on:
30+ days ago
Posted on:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
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
