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    Document Control Specialist - Irvine, California, United States - Cordis

    Cordis
    Cordis Irvine, California, United States

    3 weeks ago

    Default job background
    Permanent Administrative
    Description

    Overview:


    MedAlliance, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease.

    Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs. MedAlliance is headquartered in Switzerland, with offices in Germany, Singapore, UK and the United States (Irvine, CA).

    The Document Control Specialist position provides administrative and operational support to Document Control.

    This position interacts with multifunctional personnel in the organization, ensuring proper management of controlled documents and quality records.


    Responsibilities:
    Manages document and change control processes ensuring proper document number assignment, timely review/approval, release, and distribution of controlled documents.

    Maintains training matrix, assign training, and ensure timely completion of training in accordance with the change order implementation plan.

    Performs data entries for part updates according to document change orders.

    Performs general filing and record keeping for controlled documents and quality records.

    Assists with annual document and data review.

    Reviews and maintains documentation log/index on a regular basis to ensure data integrity.

    Assists with HR activities for onboarding process as needed.

    Provides support for audit activities as needed.

    Supports ongoing effort of process improvement activities such as CAPA and/or procedure updates.

    Performs other quality related duties as assigned.


    Qualifications:
    College degree preferred.

    1-3 years of related experience in Medical Device industry desired.

    Competencies & Skills

    Precise, Rigorous, Detail-Oriented

    Good communication and interpersonal skills.

    Supportive, keen to promote quality through example and continuous support.

    Fluent in English

    Pay / Compensation

    The expected pre-tax pay rate for this position is $ per hour

    Full time position

    Actual pay may fluctuate outside of the range depending on skills, education, experience, job-related knowledge and location.
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