Document Control Coordinator
Summary
Coordinates and maintains controlled documents for a medical-device company to meet ISO 13485 and FDA 21 CFR requirements, using an eQMS system and handling training records and audits.
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