Documentation Control Coordinator

Job Description

This role is a contract position. Trans Medics is seeking a detail-oriented Document Control Coordinator to support the implementation of an electronic Quality Management System (eQMS) and assist with Document Control Department support in a fast-paced medical device environment. This role is critical to ensuring compliance with regulatory requirements (FDA, ISO 13485, EU MDR) and maintaining robust documentation practices throughout the organization.

• Assist in the deployment and configuration of the eQMS platform
• Manage document lifecycle activities: creation, review, approval, distribution, revision, and archival
• Ensure documents meet internal formatting standards and regulatory requirements
• Maintain accurate records of controlled documents and change history
• Monitor compliance with document control policies and escalate discrepancies
• Collaborate with Quality, Regulatory, R&D, and Operations teams to streamline documentation processes
• Internal reporting for various company system metrics
• Scanning of quality documentation
• Help maintain training records within the document management system
• Perform other tasks and duties as assigned

This position does not have management responsibilities.

• Office environment
• Must be able to lift up to 30 lbs

• Minimum of 3-5 years of experience in a Documentation Control role
• High School Diploma
• Familiarity with eQMS platforms and document management systems
• Working knowledge of FDA 21 CFR Part 820, Part 11, ISO 13485, and EU MDR requirements
• Strong attention to detail and organizational skills
• Excellent communication and interpersonal abilities
• Proficiency in Microsoft Office Suite and PDF editing tools

• Medical device experience preferred
• Experience with eQMS implementation or migration projects
• Some knowledge of validation and change control processes
• Ability to manage multiple priorities in a regulated environment

• Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA
• Dental
• Vision
• Healthcare Flexible Spending Account
• Dependent Care Flexible Spending Account
• Short-Term Disability
• Long-Term Disability
• 401K Plan
• Pet insurance
• Employee Stock Purchase Plan

Trans Medics is an equal-opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability, protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.