Contract opening for a Document Controller with hands-on experience in document management, particularly within medical device manufacturing.

Responsibilities

Maintain and update controlled documentation in accordance with 21 CFR Part 820 and ISO 13485 requirements
Use an Electronic Document Management System (EDMS) to manage document workflows, revisions, and approvals
Assist in preparation for internal and external audits by organizing and retrieving quality system records
Collaborate with cross-functional teams to ensure accuracy, compliance, and timely updates of documentation
Support quality assurance and regulatory teams in document control and change management processes

Qualifications

Associate degree required
1 to 3 years of experience in document control or quality within a manufacturing environment
Prior experience in the medical device industry highly preferred
Knowledge of FDA Quality System Regulations (21 CFR Part 820) and ISO 13485 standards
Experience using EDMS platforms for document control

Document Controller - 25-00335

Contract work,