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    Document Control Coordinator - Andover, United States - TransMedics

    TransMedics
    TransMedics Andover, United States

    3 weeks ago

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    Description
    JOB DESCRIPTION

    Title: Document Control Coordinator

    Reports to: Document Control Manager

    ESSENTIAL RESPONSIBILITIES AND DUTIES INCLUDE:
    • Assist Document Control Manager with Document Control PLM system in support of other departments, in accordance with policies and procedures
    • Maintain continuity of digital files to ensure naming standards, appropriate file locations, format standardization
    • Maintain company documentation, as required
    • Internal reporting for various company system metrics
    • Issue controlled Laboratory Notebooks to cross functional departments
    • Assign VV numbers to cross functional departments
    • Maintain all Quality Records from inception to archival as hard files/electronic files
    • Ensure accuracy, quality, and integrity of all company documents
    • Ensure easy and efficient retrieval of documents internally and externally
    • Assist in updating device regulatory labels in label software
    • Assist in training and maintain training with company training process within company PLM system and hard files
    • Assist with Quality Audits
    • Update and maintain Standards Database
    • Scanning of Quality Documentation
    • Ensure ethics and compliance commitment at all times
    • Maintain confidentiality regarding sensitive documentation
    • Review and update documents for maintenance and quality control with being audit ready as the goal
    • Perform other TransMedics job-related tasks and duties, as assigned
    BACKGROUND and QUALIFICATIONS:
    • 3-5 years' experience working in a regulated industry; Quality Control experience strongly preferred
    • Proficient with Microsoft office software
    • Documentation Management Database experience preferred
    • Strong organizational skills with the ability to work with a high degree of accuracy
    • Attention to detail
    • Exceptional proof reading and quality control skills
    • Excellent interpersonal, verbal, and written communication skills. Ability to communicate effectively with all members of the company
    • Familiarity with a Quality Management System or other regulated environment and the ability to adhere to all processes and procedures
    EDUCATION:
    • High School diploma
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