Document Control Coordinator

## Document Control CoordinatorApplylocations: US-MA-Mansfield-190-Facilitytime type: Full timeposted on: Posted Todayjob requisition id: JR-6192Changing 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.SUPERVISION RECEIVED Reports to the Manager, Quality Assurance & Compliance.**ESSENTIAL DUTIES AND RESPONSIBILITIES**To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:* 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**DESIRED MINIMUM QUALIFICATIONS*** 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)* Ability to work collaboratively across functions**PHYSICAL REQUIREMENTS**Routine activities include but are not limited to: using computers, standing, walking, writing by hand, lifting, carrying, pushing, and pulling objects.Salary Pay Range:$23.28 - $31.46 USD HourlyOur salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training**.** In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation**.** Your recruiter can share more about the specific salary range for your preferred location during the hiring process.Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)). #J-18808-Ljbffr