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    Supplier Quality Engineer - Houston, United States - LanceSoft, Inc.

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    Description

    Position: Engineering Project Manager/Supplier Quality Engineer

    Location: Plymouth, MN – 55442

    Duration: 5-Month Project; until the end of this year

    Project Duration: Medium-term (1-2 years)

    Function Engagement: Medium complexity (4 — 6 functions, single site)

    Experience Level: 5-7 years overall experience, with a minimum of 3-5 years with a Master's degree

    Job Description & Requirements

    • Experience with medical device qualification processes (IQ OQ, PQ)
    • Experience in medical device product development, including key project milestones like Design Verification and Qualification timing
    • Familiarity with US FDA regulatory requirements
    • Understanding of product design and manufacturing processes for medical devices such as injection molding, assembly, extrusion, and braiding
    • Collaborates with internal and external project teams to carry out medium complexity project tasks, providing regular updates to stakeholders
    • Supervises buyer/planners regarding purchase order needs and specifications
    • Identifies, evaluates, and selects suppliers independently
    • Negotiates payment, pricing, and delivery terms for project components with minimal supervision
    • Monitors suppliers' quality, delivery, and overall performance within the project
    • Proficiency in Microsoft Project and Excel

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