Supplier Quality Engineer

Katalyst Healthcares & Life Sciences

  • Minneapolis, MN
  • 30+ days ago
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    Skills

    • Auditingunmatched
    • Continuous Improvementunmatched
    • Corrective and Preventative Action (CAPA) Systemsunmatched
    • Failure Mode and Effects Analysis (FMEA)unmatched
    • Healthcare Qualityunmatched
    • Maintain Complianceunmatched
    • Medical Equipmentunmatched
    • Process Improvementunmatched
    • Process Validationunmatched
    • Quality Engineeringunmatched
    • Quality Managementunmatched
    • Regulatory Complianceunmatched
    • Risk Analysisunmatched
    • Risk Managementunmatched
    • Vendor/Supplier Evaluationunmatched
    • Vendor/Supplier Quality Managementunmatched

    Description

    Job Summary:
    • We are seeking a Supplier Quality Engineer to support supplier transfer activities and ensure compliance with quality and regulatory standards.
    • The role involves validation execution, supplier quality management, and driving continuous improvement initiatives.
    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.

    Numbers & Facts

    LocationMinneapolis, MN

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