Document Control Coordinator

Integra LifeSciences • Mansfield, MA

5d • $23 - $31 • Onsite

About The Position

Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. The Document Control Coordinator will maintain the entire document control program to ensure compliance with domestic and international medical device regulations. This role supports the coordination, processing, and maintenance of controlled documents and training records within the Quality Management System (QMS). Responsibilities include executing document control processes, ensuring timely processing of changes, maintaining accurate records, and supporting site-wide documentation and training activities. The Document Control Coordinator partners with cross-functional teams to ensure documentation accuracy, availability, and compliance.

Requirements

• Associate degree in Business Administration or related discipline preferred
• 2–5 years of experience in document control, records management, or regulated industry environment
• Working knowledge of QSR/GMP (21 CFR Part 820) and ISO 13485 requirements preferred
• Familiarity with document control systems and electronic quality systems (e.g., Agile) preferred
• Understanding of 21 CFR Part 11 requirements preferred
• Strong organizational skills and attention to detail
• Effective written and verbal communication skills
• Ability to manage multiple priorities and meet deadlines
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, SharePoint, Adobe Acrobat)

Responsibilities

• Process document changes (e.g., SOPs, work instructions, forms) in accordance with document control procedures
• Maintain and organize controlled documentation, including DHRs, DHFs, and DMRs, ensuring accuracy and completeness
• Coordinate document review, approval, and release workflows within the electronic document management system
• Ensure timely processing of document changes to support business and regulatory requirements
• Support training record management, including assignment and tracking of training completions
• Retrieve and provide documentation in support of internal and external audits
• Ensure document storage and retention practices comply with QMS requirements
• Identify and communicate potential process improvements within document control workflows
• Maintain accurate records and ensure data integrity across systems
• Collaborate with cross-functional teams to resolve documentation or training-related issues
• Perform administrative tasks related to document control and records management as needed
• Support continuous compliance with FDA and ISO regulatory requirements
• All other tasks / duties as assigned

Benefits

• medical
• dental
• vision
• life insurance
• short- and long-term disability
• business accident insurance
• group legal insurance
• savings plan (401(k))

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree