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    Quality Engineer - Santa Clara, United States - The Fountain Group

    The Fountain Group
    The Fountain Group Santa Clara, United States

    3 weeks ago

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    Description
    Job Description

    Job Description

    This role will provide compliance support to the Regulatory Affairs organization by:
    Driving preparation of KPI dashboards and maintaining a pulse on formal RA management review and internal metrics.

    Managing strategic program for RA audit preparedness including anticipatory identification of risks, mitigation of risks identified during the audit process, and preventive actions for risks.

    Supporting quality system integration for acquisitions and new product introductions.
    Identifying and implementing system and/or systemic processes.
    Supporting tracking and maintenance of regulatory post-approval commitments.
    Driving quality system process improvement initiatives

    Initiatives include but are not limited to:
    Establishing audit support for integration products,
    Improving and Maintaining the quality system procedures (e.g., change management)

    Role has a potential for investigating nonconformances (CAPAs) and implementing mitigations.

    Exposure to Medical Device US and CE regulations, Quality Systems, a Quality role, or a Compliance role is a plus.


    List of tasks:
    RA Change Requests Tracking and Closure
    Change management

    Develop and implement an "auditing plan" for critical RA tasks (e.g., mock audits for Technical Files/Technical Documentations, Impact Assessments, Archival) as part of audit risk mitigation activities.

    CAPAs/Auding Finding management.
    Post-Approval Commitments management
    Support QMS audits from an RA perspective
    Support QMS Integration tasks
    Management Review Metrics results
    Ability to drive a problem through resolution and implement mitigations.
    Company Description The Fountain Group is a nationwide staffing firm with over 80 Fortune clients.

    Since 2001, TFG has maintained a consistent standard of excellence, and our work is broadly recognized every year through numerous industry performance awards.

    Our success is a team effort.

    Browse our website below for additional information on our company.

    The Fountain Group

    4505 Woodland Corporate Blvd, Tampa, FL 33614
    "We work in Life Sciences, Clinical, Engineering, IT, and more. Above all, we specialize in people."

    Company Description

    The Fountain Group is a nationwide staffing firm with over 80 Fortune clients.

    Since 2001, TFG has maintained a consistent standard of excellence, and our work is broadly recognized every year through numerous industry performance awards.

    Our success is a team effort.\r\rBrowse our website below for additional information on our company.\r\rThe Fountain Group\r\r4505 Woodland Corporate Blvd, Tampa, FL 33614\r"We work in Life Sciences, Clinical, Engineering, IT, and more.

    Above all, we specialize in people."
    #J-18808-Ljbffr
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