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

MINIMUM QUALIFICATIONS

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

PREFERRED QUALIFICATIONS

Medical Device experience preferred.
Experience with eQMS implementation or migration projects
Some knowledge of validation and change control processes

Job Description:

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

MINIMUM QUALIFICATIONS

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

PREFERRED QUALIFICATIONS

Medical Device experience preferred.
Experience with eQMS implementation or migration projects
Some knowledge of validation and change control processes

Documentation Control Coordinator

Documentation Control Coordinator

TransMedics

TransMedics

Benefits

TransMedics