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Manufacturing Jobs

Quality Engineer

Katalyst Healthcares & Life Sciences

  • Salt Lake, UT
  • 11 days ago

    Highlights

    An opportunity is available for an experienced Quality Engineer to support quality systems, investigations, compliance, and continuous improvement within a regulated medical-device manufacturing environment. Collaborate with manufacturing, engineering and other cross-functional teams to resolve quality issues.

    Numbers & Facts

    LocationSalt Lake, UT

    Description

    Summary:
    An opportunity is available for an experienced Quality Engineer to support quality systems, investigations, compliance, and continuous improvement within a regulated medical-device manufacturing environment.

    Roles & Responsibilities:
    • Manage and investigate nonconforming materials, products and processes
    • Support the complete CAPA lifecycle, including investigation, documentation and effectiveness activities
    • Conduct structured Root Cause Analysis (RCA) and problem-solving
    • Maintain compliance with established Quality Management System requirements
    • Support compliance with ISO 13485 and FDA 21 CFR Part 820 / QMSR requirements
    • Identify and implement quality and manufacturing process improvements
    • Apply Lean Manufacturing and Six Sigma methodologies to reduce defects and improve operational performance
    • Support inspection-ready documentation and quality records
    • Collaborate with manufacturing, engineering and other cross-functional teams to resolve quality issues
    Qualification:
    • Medical-device industry experience is mandatory
    • CAPA and Nonconformance Management experience
    • Quality investigations and Root Cause Analysis
    • Strong Quality Management Systems knowledge
    • ISO 13485 experience
    • FDA QMSR / 21 CFR Part 820 knowledge
    • Continuous improvement and process-improvement experience
    • Lean Manufacturing / Six Sigma knowledge
    • Experience working within highly regulated manufacturing environments

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