Documentation Control Coordinator (Contract)

Requirements

• Minimum of 3 - 5 years' experience in 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
• Every Organ Wasted is a Life Not Saved.
• Driven by a passion for improving patient care, we make the impossible possible and keep our employees at the center of everything we do. Together, we strive to enhance the quality of life for transplant recipients and their families, fostering hope and healing in the journey toward better health.
• Employee Benefit:
• 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

Benefits

Additional Information

Job Description: This role is contract position. TransMedics is seeking a detailed oriented Document Control Coordinator to support the implementation of an electronic Quality Management System (eQMS) and assisting 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. This position is responsible for, but not limited to, the following: 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 metricsthe goal Scanning of Quality Documentation Help to maintain training records within the document management system Perform other TransMedics job-related tasks and duties, as assigned MANAGEMENT RESPONSIBILITIES This position manages the following positions on a daily basis. This position will not have management responsibilities. PHYSICAL ATTRIBUTES Office environment Must be able to lift up to 30lbs

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