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    Engineer, QA - Raleigh, United States - Stryker

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    Description


    Manufacturing Quality Engineer role is to implement a unified approach to Quality in Stryker with the intent to deliver high quality products and services in a manner that meets the high standards held by Stryker.


    Responsibilities:
    This role will provide support to the Site Quality team to ensure compliance to technical, regulatory and Stryker requirements.
    Executing Change Managements & Manufacturing Changes associated with Machine moves, Process changes, validation updates.
    Executing Production part approval process for any change request.
    Good hands-on experience on Validation (Validation PSPs, EQ, MSA execution)
    NC/ CAPA for internal Manufacturing issues (Clean, Pack, Label, Gage)
    Driving Internal Continuous Improvement projects at Site.
    Executing Gage Evaluation from QT's & focus on Gage/ fixture Updates & Development.
    Reviewing & providing inputs on Supplier Material Certificates.
    Ownership for site quality performance and measurement including KPI's and participate in supplier performance reviews.
    Support quality issues with site & partner with Internal Customers; Lead effective supplier containment and

    corrections/corrective

    action.
    Provide support to Internal/ External Customer groups on compliance issues related to assigned sites.

    Participate in cross- functional teams in the development of new products or changes related to current products in meeting customer requirements.

    Applies sound, systematic problem-solving methodologies (5Why, DMAIC, 8D, C&E) in identifying, prioritizing, communicating, and resolving quality issues - NC & CAPA.


    Professional Requirements:
    B.Tech

    (Electronics/Electrical/Mechanical)


    with 4-7 years of experience in Quality / Engineering / Manufacturing environment, preferably from medical industry with ISO 13485 auditor certification is a must.

    Intermediate level ability to use most MS tools (Word, Excel, PowerPoint, etc.)
    Supplier Quality Processes/ Tools

    • Working knowledge of basic and advanced Quality tools such as; Six Sigma, SPC, FMEA, Control Plans, Root Cause Analysis, Poke Yoke, Kaizen, Lean Manufacturing etc.
    Executes/ Masters & implements/ improve all supplier quality tools/ Processes

    . Trains supplier in these tools effectively.
    Commodity Domain Knowledge –

    Strong Knowledge & understands technology, regulatory requirement related to product, system & services. Determine supplier technical abilities based on these knowledges.

    #J-18808-Ljbffr


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