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    Supplier Quality Engineer II - Hialeah, United States - Katalyst Healthcares and Life Sciences

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    Description

    Responsibilities:
    Ensures that suppliers deliver quality parts, materials, and services.

    Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.

    Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier related problems as they occur. Builds a collaborative relationship with suppliers to quickly address any non-conformances. Drive appropriate root cause investigations with the supplier. Ensure corrective actions are implemented and monitor for desired results. Work with the supply base to drive corrective/preventative action. Based on feedback from incoming inspection, Healthcare/supplier internal quality metrics and customer complaints.

    Review/prepare test plans and reports (qualification, validation) for change and improvement activities (supplier certifications, material/sub-supplier changes and supplier performed special processes).

    Collaborates with the operating platform to address issues and gain alignment when required.

    Collaborates with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products.

    Define Receiving Inspection requirements as required and associated test method validation for all internal Healthcare Test Methods. Lead PPAP execution with supplier and ensure robust supplier process qualification/validation through IQ, OQ & PQ methodology. Perform supplier audits.

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