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    Document Control Specialist - Alameda, United States - iota Biosciences, Inc.

    iota Biosciences, Inc.
    iota Biosciences, Inc. Alameda, United States

    3 weeks ago

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    Description


    We are looking for a Document Control Specialist who is highly motivated and passionate to manage quality system and product supporting documentation for novel Class III active implantable devices.


    The Document Control Specialist will be expected to:


    • Serve as the Document Control reviewer and/or approver, ensuring documents/records and changes comply with established procedures and requirements, and ensuring change elements are identified, compliant, and assembled for review and approval
    • Promptly process Document/Engineering Change Requests and Change Orders (DCR, DCO, ECR, ECO) in compliance with Document and Record Control processes
    • Ensure appropriate functional area representatives are involved in review and/or approval
    • Process and archive paper and electronic quality records; review for compliance to applicable standards
    • Implement employee training on documents, SOPs, and procedures
    • Track, manage and report training compliance on continuous basis
    • Coordinate new hire onboarding processes as related to the QMS
    • Deliver change control data, reports, and information upon request
    • Deliver Regulatory submission requests for documentation upon request
    • Assist in projects for continuous improvement of the eQMS
    Qualifications:


    • Bachelor's degree
    • Minimum two years of relevant experience, preferably in a Quality function in the Medical Device or regulated industry
    • Organized, self-motivated, ability to effectively manage multiple projects and priorities; high attention to detail
    • Effective interpersonal and communication and writing skills
    $65,000 - $85,000 a year
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