Document Control Specialist

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