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    Engineer - Irvine, United States - Tata Consultancy Services

    Tata Consultancy Services background
    Description

    Job Title

    SeniorSupplier Quality Engineer


    Relevant Experience

    (in Yrs)

    A minimum of Technical/EngineeringDegree with 8+ years of related experience Medical Device Supplier Qualitydomain.


    Technical/FunctionalSkills


    • Working knowledge of regulatorycompliance requirements (i.e. Quality System Regulations (QSRs), MedicalDevice Directive (MDD), ISO 9001, ISO 13485, ISO 14971 or other internationalstandards) required
    • Provides overall quality assuranceleadership in the management of Direct, Indirect Suppliers and/or ExternalManufacturers engaged in the production of Johnson and Johnson products.
    • Leads the deployment of the SupplierQuality Management (SQM) strategies and associated standards, policies,procedures, programs, systems, processes, and initiatives for suppliers ofthe CSS supply chain.
    • Collaborate with StrategicSourcing/Procurement, R&D, Engineering / Technical Operations, Quality,Operations, business partners/stakeholders, and external suppliers toimplement solutions and improve suppliers quality and overall service andperformance.
    • Supports the execution ofplans/strategies, and impl ementation of systems, processes, and procedures toensure robust supplier/purchasing controls with regards to the determination,selection, qualification, monitoring, and disengagement of suppliers.
    • Excellence (PEx) tools in support ofsupplier-related changes, risk management,
    • Product/process transfers,innovations, and continuous process enhancements to improve supplierreliability, minimize risks, and ensure sustainable sources of materialsupply capable of meeting or exceeding Quality, Compliance, and Businessrequirements

    Experience Required

    A minimum of 7 years of experience in Quality Engineeringor Quality Assurance,

    including data analysis, risk assessment and riskmitigation is required. Working experience in good manufacturing practiceregulated environment is preferred.

    (Medical device, pharmaceutical,etc.).


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