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    Quality Engineer With Medical Device - Los Angeles, United States - MasterCompliance LLC

    MasterCompliance LLC
    MasterCompliance LLC Los Angeles, United States

    3 weeks ago

    Default job background
    Description

    HM's top needs:

    Below covers everything you need to know about what this opportunity entails, as well as what is expected from applicants.
    • Post-Market Quality Engineering experience
    • Highly prefer product quality support vs manufacturing, testing or supplier quality experience
    • Extended Core Team experience for product launch / later stage product development

    Education Required: Bachelor's in engineering, science or technology discipline

    Years' Experience Required: 4-10 years preferred.

    Will the contractor be working 40 hours a week? If not, weekly estimate? 40 hours weekly

    Responsibilities include the following but not limited to:

    • Develops, modifies, and maintains quality system procedures.
    • Supports internal or external audit activities where needed.
    • Supports nonconformance investigations and dispositions.
    • Collaborates with operations, manufacturing, engineering, and regulatory functions to ensure quality standards are in place.
    • Supports new product introduction activities with product design transfer efforts, reviewing and approving plans and reports and supporting design qualifications.
    • Understand complex issues and consult with various functions to conduct meaningful analyses.
    • Training and coaching cross-functional peers on maintaining compliance to internal and external Quality requirements and regulations.
    • Driving clarity and consistency in documentation.
    • Leading CAPA projects and assisting with post market analysis.
    • Work under consultative direction toward predetermined long-range goals and objectives. Determine and pursue courses of action necessary to obtain desired results through consultation and agreement with others rather than by formal review of superior.
    • Participate on extended Quality core team for new products and serves as voice of post-market quality engineering.

    Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

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