Document Control Specialist

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Culver City, CA
$60,000 - $75,000
Job Type
Direct Hire
Bachelor of Science
Apr 19, 2018
Job ID

Document Control Specialist

We are searching for a Document Control Specialist for a start up medical device company in the Culver City area. 

The Document Control Specialist will be responsible for managing and improving the Document Control activities/processes and maintaining employee training matrix and files. 

Responsibilities for Document Control Specialist:

  • Lead in the and coordination and processing of the document control function to ensure version control, trace-ability/logging, and location/security of documents including paper &/ electronic quality systems management and its archival.
  • Timely release of document change orders with accuracy
  • Review, log and archive quality documentation to verify completeness, legibility and formatting
  • Coordinate logistics of the change management program for controlled document and assist with the change management program for product changes
  • Responsible for maintaining and sustaining the change control system and supporting all Document Control activities for 21 CFR Part 820 and ISO-13485 processes.
  • Management of the employee training files and records. Responsible for reports for training compliance to QA
  • Perform data verification and consistency/number checking tasks against approved source documents on clinical, regulatory and development documents

Requirements for Document Control Specialist:

  • Bachelors degree preferred
  • Advanced knowledge in quality control of quality system and training documentation
  • 3+ years experience managing document control system and processes preferably in the medical device industry
  • Working knowledge of ISO 13485, MDD 93/42/EEC, 21 CFR PART 820 preferred
  • Exceptional organization, multi-tasking skills and problem-solving capabilities
  • Ability to work independently and prioritize with minimal daily instruction
  • Demonstrated analytical skills with high attention to detail