Senior Supplier Quality Engineer

    Highlights

    Roles & Responsibilities: Develop and qualify injection molding processes and production cells. Partner directly with molding suppliers on quality and process capability.

    Numbers & Facts

    LocationLincoln, NE

    Description

    Roles & Responsibilities:
    • Develop and qualify injection molding processes and production cells.
    • Lead mold design reviews and supplier tooling development.
    • Qualify new molds and molding processes for production.
    • Troubleshoot molding defects and drive RCA/CAPA activities.
    • Partner directly with molding suppliers on quality and process capability.
    • Support supplier qualification, NPI and sustaining programs.
    • Drive continuous improvement and ensure regulatory compliance.

    Requirements:
    • 9+ Yea rs Medical Device Experience.
    • Plastic Injection Molding Large / Complex Parts.
    • Injection Molding Process & Production Cell Qualification.
    • Mold Design Reviews & Tooling Development.
    • New Mold & Process Qualification.
    • IQ / OQ / PQ & Process Validation.
    • Injection Molding Defect Troubleshooting.
    • Root Cause Analysis & Corrective Actions.
    • CAPA / SCAR.
    • Process Capability & Supplier Quality.
    • Supplier Qualification / NPI / Sustaining Quality.
    • FDA & ISO 13485 Environment.
    • Bachelor's Degree in Engineering or Related Field.

    Similar Jobs