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    Quality Systems Specialist - Rocklin, United States - Randstad Life Sciences

    Randstad Life Sciences
    Randstad Life Sciences Rocklin, United States

    3 days ago

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    Description

    Quality Systems Specialist Position at Innovative Company

    Location: Rocklin, CA

    Contract: 1 Year

    Rate: $25-30/hr

    Description:

    • The Quality Systems Specialist, as part of the Quality team, plays a crucial role in ensuring compliance with various regulations (ISO13485, MDSAP, IVDD/IVDR, CFR 21, GxP) and maintaining the quality management system. Collaborating cross-functionally, this position contributes to enhancing product quality and process efficiencies. Additionally, the Specialist prepares essential documents and reports for metrics and management reviews.

    Responsibilities:

    • Ensure document compliance with company procedures and regulatory standards.
    • Review and audit DHFs and technical files, including various reports and plans.
    • Assess data quality and documentation practices, offering feedback and support.
    • Maintain and update SOPs, staying abreast of company policies and procedures.
    • Participate in internal and external audits, supporting continuous improvement efforts.
    • Adhere to quality standards, company values, and regulatory requirements.
    • Collaborate with stakeholders to address and resolve quality issues effectively.
    • Conduct training for staff members as needed.
    • Take proactive measures to suggest and implement process improvements.
    • Flexibility to work weekends or extended hours when necessary.
    • Approve quality documents, ensuring compliance with relevant standards.
    • Undertake any other duties as assigned.

    About the Company:

    A reputable company engaged in impactful work within the industry, fostering a culture of innovation and excellence.

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