Job Description

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

Job Tags

Similar Jobs