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Supplier Quality Engineer

Karwell Technologies

  • Salt Lake, UT
  • 30+ days ago

    Highlights

    We are seeking an experienced Supplier Quality Engineer (SQE) with a strong background in the Medical Device industry to support supplier quality, compliance, and process validation activities. 8+ years of Supplier Quality experience in the Medical Device industry Strong knowledge of quality systems, supplier quality processes, and regulatory requirements.

    Numbers & Facts

    LocationSalt Lake, UT

    Description

    Summary :
    We are seeking an experienced Supplier Quality Engineer (SQE) with a strong background in the Medical Device industry to support supplier quality, compliance, and process validation activities.
    Key Responsibilities:
    • Ensure suppliers consistently deliver quality parts, materials, and services meeting company requirements.
    • Evaluate and onboard suppliers into the Approved Supplier List (ASL).
    • Review and approve PPAP documentation, Control Plans, Process Flow Charts, Capability Studies, DFMEA, and PFMEA.
    • Conduct supplier risk assessments and maintain supplier risk profiles.
    • Facilitate Supplier Quality Agreements and conduct supplier audits.
    • Support Process Validation activities (IQ, OQ, PQ), MSA/TMV, and Control Plans.
    • Coordinate supplier evaluation and selection activities for new suppliers and process changes.
    • Manage documentation within PLM systems and ensure timely approvals and releases.
    • Collaborate with global quality teams on Supplier Data Review (SDR) and Supplier Owned Quality (SOQ) initiatives.
    Required Qualifications:
    • Bachelor's degree in Engineering, Technical, or Scientific discipline.
    • 8+ years of Supplier Quality experience in the Medical Device industry Strong knowledge of quality systems, supplier quality processes, and regulatory requirements.
    • Experience with PPAP, DFMEA, PFMEA, MSA, Risk Management, and Process Validation (IQ/OQ/PQ).
    • Experience working with PLM systems and quality documentation tools.

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