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Supplier Quality Engineer

Katalyst Healthcares & Life Sciences

  • Plymouth, MN
  • 30+ days ago

    Highlights

    Summary : We are seeking an experienced Supplier Quality Engineer with a strong background in the Medical Device industry to support supplier quality, incoming inspection, and manufacturing quality initiatives. Roles & responsibilities : Drive supplier quality and incoming inspection activities Analyze material non-conformanc...

    Numbers & Facts

    LocationPlymouth, MN

    Description

    Summary :
    We are seeking an experienced Supplier Quality Engineer with a strong background in the Medical Device industry to support supplier quality, incoming inspection, and manufacturing quality initiatives.

    Roles & responsibilities :
    • Drive supplier quality and incoming inspection activities
    • Analyze material non-conformances and work directly with suppliers on resolution
    • Support component selection, qualification, and reliability assessments
    • Review product designs for quality and manufacturability
    • Lead supplier investigations, root cause analysis, and corrective actions
    Education & Experience :
    • 5+ years of experience in Manufacturing Engineering, Supplier Quality, or Quality Engineering within Medical Devices
    • Hands-on experience with Supplier Quality Engineering, Receiving Inspection, and supplier management
    • Experience with SAP (Quality/Supply Chain modules) or similar ERP systems
    • Knowledge of Windchill or other document control systems for change management and BOM updates
    • Experience developing inspection procedures, quality plans, and inspection tooling
    • Ability to support component qualification, testing, validation, and approval activities
    • Strong collaboration with Design Engineering on component quality, reliability, and manufacturability
    • Experience investigating supplier-related quality issues, material defects, and corrective actions (CAPA)
    • Knowledge of FDA regulations, GMP, ISO 13485, and ISO 14971

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