What are the responsibilities and job description for the Document Control Specialist position at United Pharma?
We are looking for a Document Control Specialist with strong experience in medical device environments to support PLM systems and document change control activities.
Key Responsibilities:
- Manage engineering & quality documents within PLM
- Handle document change control (ECO/ECR)
- Create, review, route, and archive documents
- Ensure compliance with **ISO 13485 & **FDA 21 CFR Part 820
- Support audits and cross-functional teams
Requirements:
• 6–8 years of experience in document control
• Medical device or regulated industry experience required
• Strong knowledge of QMS and regulatory standards
• Hands-on experience with PLM/eQMS systems
• Excellent attention to detail and coordination skills