Supplier Quality Engineer II - Hialeah, United States - Planet Pharma

    Planet Pharma
    Planet Pharma Hialeah, United States

    1 month ago

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    Description

    (This is an 11-month contract with potential to extend/convert)

    Responsibilities may include the following and other duties may be assigned:

    • 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, company/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 Test Methods.
    • Lead PPAP execution with supplier and ensure robust supplier process qualification/validation through IQ, OQ & PQ methodology
    • Perform supplier audits.

    Must Have:

    • Bachelors degree in Engineering
    • Change Control
    • Develop/Update PFMEA, Control Plans and Process Flows
    • Experience with multiple root cause investigation techniques
    • Managed the PPAP activities

    Nice To Have:

    • Certifications: ISO 13485 Lead Auditor
    • Familiarity with medical device regulations and good manufacturing practices
    • Manage Supplier Change Requests
    • Previous SQE experience

    2 openings

    W2 Contract starting 11-months

    Hybrid in Miami Lakes, FL (2 days/week remote)

    Hours: 40 hours per week

    Pay Range: $28-38/hr