Assist in supporting external audits, coordinating activities, and ensuring timely response to documentation requests for auditors. Supports change management and ensures accurate and successful completion of document change requests.
Numbers & Facts
Location
Ham Lake, Minnesota
Description
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.