Job Description

The Senior Document Control Specialist role has primary responsibility for managing the Document Control System. They will assist with the development and implementation of standard operating procedures (SOPs) in compliance with applicable FDA, ISO-13485, and CE guidance.

Job Functions

  • Responsible for the execution of document control activities, ensuring compliance to applicable medical device Quality Management System (QMS) policies and procedures
  • Maintain executed forms (e.g. design, development, production, labeling and distribution records) and associated regulations or standards (e.g., US QSR, ISO 13485)
  • Control and trace QMS documents through maintenance of logs, databases, and catalogues
  • Periodically review, inspect, and assess QMS documentation (e.g. design, develop, produce, and distribute forms and templates for compliance to QMS policies and procedures for compliance with US 21CFR11 and US 21CFR820)
  • Prepare status reports; assign and monitor document and part numbers
  • Review documents for completeness and compliance
  • Support design reviews, capture meeting minutes, and action items
  • Maintain Design History, Risk Management and Usability Engineering files
  • Assist in compiling regulatory filing documents
  • Work with Quality Manager to monitor quality processes

Education & Experience

  • 3-5 years working in Document Control or an administrative Quality role in the medical devices or related industry
  • Working experience using document management systems
  • Working knowledge of US and international regulations including FDA, ISO, and cGMP guidance documents

Preferred Skills and Experience

  • Bachelor’s degree in a related field is an asset
  • Word, Excel, Jira, and Airtable
  • Greenlight Guru or other eQMS software

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