Document Control Coordinator
$62,400–$74,880 year
On-siteHam Lake, Minnesota, United States
Job Summary
Maintain document compliance with ISO 13485 and FDA 21 CFR guidelines while administering the annual training review process. Perform the Document Control function within the eQMS system, supporting user requests and training staff on system usage. Coordinate controlled documentation, manage training set-up and record retention, and assist with document redlines and new document creation. Verify documents meet formatting standards before release and track hard copy distribution and logbook reconciliation. Support change management, ensure audit readiness, investigate corrective actions, and prepare performance metrics for Management Review. Assist in supporting external audits and coordinating activities.
Required Qualifications
- ISO 13485
- FDA 21 CFR guidelines
- eQMS system
- Standard Operating Procedures (SOP)
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