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  • Quality Management Systems Engineer - Irvine - SysMind Tech

    SysMind Tech
    SysMind Tech Irvine

    1 week ago

    Default job background
    Description

    Job Title: Engineer

    Summary:

    We are seeking a skilled Engineer to lead our Quality Management Systems, ensuring compliance with FDA regulations and presenting complex information effectively. The ideal candidate will possess strong communication skills and experience with ISO 13485, Medical Device, and Regulatory Standards.

    Key Responsibilities:

    • Provides overall quality assurance leadership in the management of direct and indirect suppliers engaged in the production of Johnson and Johnson products.
    • Leads the deployment of Supplier Quality Management (SQM) strategies and associated standards, policies, procedures, programs, systems, processes, and initiatives for suppliers of the CSS supply chain.
    • Collaborates with suppliers for documentation and onboarding in the ASL system.
    • Supports trainings for stakeholders and collaborates with Strategic Sourcing/Procurement, R&D, Engineering/Technical Operations, Quality, Operations, business partners/stakeholders, and external suppliers to implement solutions and improve supplier quality and overall service and performance.
    • Supports the execution of plans/strategies, implementation of systems, processes, and procedures to ensure robust supplier/purchasing controls with regards to the determination, selection, qualification, monitoring, and disengagement of suppliers.

    Requirements:

    • A minimum of Technical/Engineering Degree with 8+ years of related experience in Medical Device Supplier Quality domain.
    • Working knowledge of regulatory compliance requirements (i.e. Quality System Regulations (QSRs), Medical Device Directive (MDD), ISO 9001, ISO 13485, ISO 14971 or other international standards).
    • Experience in good manufacturing practice regulated environment is preferred (medical device, pharmaceutical, etc.).

    Desirable Skills:

    • A minimum of 7 years of experience in Quality Engineering or Quality Assurance, including data analysis, risk assessment, and risk mitigation.
    • Collaborate with suppliers and business partners to ensure robust materials, products, processes, and systems.

    Qualifications:

    • Excellence (PEx) tools in support of supplier-related changes, risk management, product/process transfers, innovations, and continuous process enhancements to improve supplier reliability, minimize risks, and ensure sustainable sources of material supply capable of meeting or exceeding Quality, Compliance, and Business requirements.
    • Comply with all applicable quality management system, environmental, safety, and occupational health policies (for example, ISO 13485, ISO14001 & OSHAS18001).

    Location:

    United States

    Branch | City | Location:

    TCS - Los Angeles
    IRVINE
    Irvine, CA


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