Quality Engineer - Medical Devices Job at Stark Pharma Solutions Inc, Minneapolis, MN

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  • Stark Pharma Solutions Inc
  • Minneapolis, MN

Job Description

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

Job Tags

Contract work

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