Document Control Specialist - job 1 of 2

Job Summary

A company is looking for a Document Control Specialist to support the Quality Management System.

Key Responsibilities

• Manage the lifecycle of controlled quality documents including SOPs and Work Instructions
• Maintain document control processes in compliance with ISO 13485, MDSAP, and FDA regulations
• Support audits by ensuring document readiness and compliance with applicable standards

Required Qualifications

• 3+ years of document control experience in the medical device, biotech, or pharma industry
• Working knowledge of ISO 13485, MDSAP, and FDA 21 CFR Part 820
• Familiarity with EU MDR/IVDR document requirements or willingness to learn
• Experience with eQMS platforms or structured document management systems
• Associate or Bachelor's degree preferred but not required