Documentation Control Coordinator (Contract)

TransMedics, Inc.; Andover (MA); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

Medical with Health Reimbursement Account

Dental

Vision

Short Term Disability

Long Term Disability

401K Plan

Pet insurance

Employee Stock Purchase Plan

Job summary

TransMedics, Inc. is seeking a Document Control Coordinator for a contract position to support the implementation of an electronic Quality Management System (eQMS). This role involves managing document lifecycle activities and ensuring compliance with regulatory requirements (FDA, ISO 13485, EU MDR) in a fast-paced medical device environment.

The ideal candidate will have 3-5 years of experience in documentation control, a High School Diploma, and proficiency in Microsoft Office. Benefits include medical, dental, vision insurance, and a 401K plan.

Qualifications

• 3 – 5 years’ experience in a 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 requirements.

Responsibilities

• Assist in deploying and configuring the eQMS platform.
• Manage document lifecycle activities: creation, review, approval, and archival.
• Collaborate with teams to streamline documentation processes.

Skills

Detail-oriented

Interpersonal skills

Organizational skills

Attention to detail

Proficiency in Microsoft Office Suite

Education

High School Diploma

Tools

PDF editing tools

eQMS platforms

Job description

Job Description: 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. The position ensures compliance with regulatory requirements (FDA, ISO 13485, EU MDR) and maintains 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.
• Scanning of Quality Documentation.
• Help maintain training records within the document management system.
• Perform other TransMedics job‑related tasks and duties, as assigned.

Minimum Qualifications

• Minimum of 3 – 5 years’ 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.

Preferred Qualifications

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

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.

Physical Attributes

Office environment; must be able to lift up to 30 lbs.

Management Responsibilities

This position will not have management responsibilities.

EEO Statement

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