Documentation Control Coordinator (Contract)

About the role

This role is a contract position. TransMedics is seeking a detailed-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.

Responsibilities

• 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
• Help to maintain training records within the document management system
• Perform other TransMedics job-related tasks and duties, as assigned

Requirements

• Minimum of 3 - 5 years’ experience in Documentation Control role
• Familiarity with eQMS platforms and document management systems
• Working knowledge of FDA 21 CFR Part 820, Part 11, ISO 13485, and EU MDR

Qualifications

• Strong attention to detail and organizational skills
• Excellent communication and interpersonal abilities
• Proficiency in Microsoft Office Suite and PDF editing tools

Skills

• None specified

Benefits

• 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

Pay

N/A

Schedule

N/A