Document Control Specialist

1 month ago


Dublin, Dublin City, Ireland Cook Medical Incorporated Full time
Overview

The primary function of this role is to ensure regulatory adherence of Cook Medicalsdocument control process.

Reporting to: Manager, Quality Systems

Responsibilities
  • • Change Analyst within the Agile Product Lifecycle Management (PLM) system.
    • Processing and GMP / GDP review of Change Orders (CO's).
    • Ensure Change Orders are implemented fully.
    • Maintenance, control and distribution of Quality System documentation.
    • Obsolete and distribute Quality Management System documents.
    • Maintenance and control of the Document log.
    • Generation and distribution of data on the effectiveness of the Documentation system.
    • Global Part Number (GPN) Assignment and CIMS update for non Cook Irelandproduct.
    • Bill of Material (BOM) updates.
    • Supply Chain updates for non Cook Ireland product.
    • Global Product File (GPF) updates and maintenance of the GPF.
    • IFU/PFI File Management updates.
    • Implementation of Global Document Control processes and systems as appropriate.
    • Management and maintenance of Quality Systems records.
    • Participation in Internal Audits if desired.
    • Support External Audits where required.
    • Provide training on Quality System procedures where required.
    • Ability to lead and drive assigned Process Improvements within the DocumentControl Department essential.
    • Ensure that Cook's Code of Conduct is considered in all business matters carried outon Cook's behalf.
Qualifications
  • Cert/Diploma in Quality related discipline desirable.
    • Excellent PC skills, particularly Microsoft Office.
    • Previous experience of working in a Quality environment would be advantageous.
    • A self starter and motivated to learn all aspects of the role.
    • Ability to work independently but also work well as part of a team.
    • High attention to detail.
    • Strong interpersonal skills with the ability to communicate effectively at allorganisational levels.
    • Project Management abilities highly desirable.
    • Strong organizational skills. Ability to set priorities, develop a work schedule,monitor progress towards goals, and track details/data/information/activities.Rev 7, Last Reviewed: 17 April 2024
    • Willingness and availability to travel on company business.
    • Qualified and experienced Quality Auditor desirable but not essential.
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