Document Control Coordinator

Burke Porter, an Ascential Technologies Brand • Andover, MN

4d • $30 - $36

About The Position

The Document Control Coordinator is responsible for maintaining document compliance with ISO 13485 and FDA 21 CFR guidelines. This role manages training set-up and record retention, administers the annual training review process, and oversees the overall coordination of controlled documentation within the company. The coordinator performs the Document Control function within the eQMS system, supports user requests for documentation, and trains users in the eQMS system. Additionally, this position supports change management, ensures accurate completion of document change requests, and assists with the implementation of documentation, procedures, and specifications. The role also verifies new and revised documents meet formatting and template standards, tracks and maintains the distribution of hard copies, and assists in supporting external audits. The Document Control Coordinator maintains quality records, investigates and responds to corrective actions related to Document Control activities, and tracks performance metrics for Management Review.

Requirements

• Knowledge of ISO 13485 and FDA 21 CFR guidelines.
• Experience with eQMS systems.
• Ability to train users in eQMS systems.
• Understanding of change management processes.
• Familiarity with document redlining and creation.
• Experience with document formatting and template standards.
• Proficiency in tracking and maintaining distribution of hard copies.
• Experience supporting external audits and responding to auditor requests.
• Knowledge of Standard Operating Procedures (SOPs).
• Experience investigating and responding to corrective actions.
• Ability to track performance metrics and prepare data for Management Review.

Responsibilities

• Maintain document compliance with ISO 13485 and FDA 21 CFR guidelines.
• Manage training set-up and record retention.
• Administer the annual training review process to ensure employee training records remain current.
• Oversee the overall coordination of controlled documentation within the company.
• Perform the Document Control function within the eQMS system.
• Support user requests for documentation and train users in the eQMS system.
• Support change management and ensure accurate and successful completion of document change requests.
• Support the implementation of documentation, procedures, and specifications.
• Ensure compliance to document control, regulatory, and training requirements.
• Assist with the review of document redlines and creation of new documents.
• Verify 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.
• Maintain quality records per applicable Standard Operating Procedures (SOP).
• Investigate and respond to corrective actions related to Document Control activities.
• Track performance metrics and prepare data for Management Review.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed