Jobs · Quality Assurance · Minnesota

Supplier Quality Engineer

Katalyst CRO · Minneapolis, MN · 2 mo ago
On-siteQuality AssuranceContract

Job Summary

Roles & Responsibilities

  • Lead supplier transfer and qualification activities
  • Execute validations (IQ/OQ/PQ)
  • Manage quality agreements with suppliers
  • Handle Client/CAPA investigations and resolutions
  • Conduct supplier audits and ensure compliance
  • Perform risk management activities (FMEA, risk assessments)

Experience

  • Experience in supplier quality within medical device or regulated industry
  • Strong knowledge of IQ/OQ/PQ validations
  • Hands-on experience with Client/CAPA and audits
  • Familiarity with risk management processes
  • Ability to work onsite and start immediately

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