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Document Control Specialist

Connexion Systems & Engineering, Inc.

Job Description

Job Description

Document Control Specialist

JOB SUMMARY : Manage, administer, and improve the Document Control system, including but not limited to managing document control, deviations and training. 

ESSENTIAL FUNCTIONS:  
  • Continually explore and learn companies Electronic Quality Management System (eQMS) and teach others to use it
  • Review high volumes of data and process ECNs, deviations and training items in eQMS
  • Investigate discrepancies and/or missing information or documents
  • Review and approve key document control and training workflows for compliance and clarity
  • Review system status and prompt users to complete open items as needed
  • Participate in continual improvement efforts related to QMS processes
  • Manage manual data transfers between the eQMS system and other systems (e.g. ERP system)
  • Manage paper documentation and records as required for non-electronic systems (e.g. Device History Records and training records)

    QUALIFICATIONS:
  • Good written and verbal communication skills.
  • Attention to detail is very important
  • Ability to learn new operating systems
  • 3-5 years of experience in Document Control and/or Change Control, preferably including familiarity with engineering changes, bills of material, procedures, ERP systems, and engineering drawings
  • Proficiency with Microsoft Office tools.

Desirable additional qualifications:

    • Experience with SolidWorks and SolidWorks PDM
    • Familiarity with ISO 13485, ISO 9001, or other quality system standards
    • Experience and comfortable with eQMS and ERP software, ideally Propel and Sage, but including Agile, Windchill, Trackwise, or similar systems
    • Experience working in a production environment
Vacancy posted 2 days ago
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