Document Control Coordinator

ESSENTIAL RESPONSIBILITIES

• Responsible for maintaining document compliance with ISO 13485 and FDA 21 CFR guidelines.


• Manages training set-up and record retention.


• Administers the annual training review process to ensure employee training records remain current.


• Responsible for overall coordination of controlled documentation within the company.


• Performs the Document Control function within the eQMS system.


• Supports user requests for documentation and trains users in eQMS system.


• Supports change management and ensures accurate and successful completion of document change requests.


• Support the implementation of documentation, procedures, and specifications.


• Ensures compliance to document control, regulatory and training requirements.


• Assist with review of document redlines and creation of new documents.


• Verifies new and revised documents meet formatting and template standards prior to release.


• Track and maintain the distribution of hard copies, including issuance and reconciliation of logbooks.


• Assist in supporting external audits, coordinating activities, and ensuring timely response to documentation requests for auditors.


• Maintains quality records per applicable Standard Operating Procedures (SOP).


• Investigates and responds to corrective actions related to Document Control activities.


• Track performance metrics and prepare data for Management Review.

Pay Range:  $30-$36 per hour