Document Control Specialist III

Document Control Specialist III manages controlled documents in the medical device industry, ensuring compliance with FDA and ISO standards. The role supports cross-functional teams, leads document control operations, and manages complex document change initiatives.

Requirements

• Associates degree or equivalent experience
• 5+ years working experience in medical device document control or quality systems
• Deep knowledge of FDA 21 CFR Part 820 (cGMP), ISO 13485 and global regulatory requirements
• Experience with electronic quality management systems, preferably MasterControl
• High attention to detail in document formatting, numbering, and data entry
• Sound verbal and written communication with Cross-functional members

Benefits

• Health insurance
• Dental insurance
• Vision insurance
• 401(k) plan plus employer contribution and match
• Paid vacation
• Paid sick leave
• Paid volunteer time
• Performance bonus incentive plan
• Wellbeing programs