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