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

    The Fountain Group
    The Fountain Group Santa Clara, United States

    2 weeks ago

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    Description
    The Fountain Group is currently seeking a ­­­­­­­­Quality Engineer for a prominent client of ours. This position is located in ­­Santa Clara, CA.

    Details for the position are as follows:

    Pay Range:
    $45-53/hr

    Contract until end of year with possible extension or conversion

    Hybrid schedule (3 days onsite / 2 days remote)


    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.


    Tracking new regulatory requirements for emerging issues, will work with international affiliates to understand impact, implement Quality Systems controls, processes / procedures that we need to abide by.

    Will also work on CAPA's, QI/Quality Investigations, declarations of conformity, COE's and other high level operational activities.


    Establishing audit support for integration products, improving and maintaining the quality system procedures (e.g., change management), liaising with cross-functional partners and international affiliates to meet audit compliance needs and driving to implementation/resolution, participating in audit backrooms.


    Qualifications:
    Bachelor's degree

    Quality systems / compliance experience


    If you are interested in hearing more about the position, please respond to this posting with your resume attached or contact me at (phone number removed).

    Please forward this email to any friends or colleagues as we do offer aReferral Bonusfor any candidate hired.
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