Documentation Control Coordinator (Contract)

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 Ability to manage multiple priorities in a regulated environment Every Organ Wasted is a Life Not Saved. TransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. Our mission is to help save more patients' lives by increasing access to viable donor organs for those who are awaiting an organ transplant. To accomplish this mission, we partner closely with transplant stakeholders worldwide and help expand their access to healthy donor organs, while delivering the highest quality technology, service, clinical care and outcomes. 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 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. Welcome to TransMedics Careers! Our Vision is to help save more patients' lives by becoming the trusted partner to transplant stakeholders worldwide and delivering the highest quality technology, service and clinical care. TransMedics Group, Inc. (TMDX) is a commercial-stage medical technology company transforming organ transplant therapy for end-stage organ failure patients across multiple disease states. We developed the Organ Care System, or the OCS™, to replace a decades-old standard of care that we believe is significantly limiting access to life-saving transplant therapy for hundreds of thousands of patients worldwide. Our innovative OCS technology replicates many aspects of the organ's natural living and functioning environment outside of the human body. As such, the OCS represents a paradigm shift that transforms organ preservation for transplantation from a static state to a dynamic environment that enables new capabilities, including organ optimization and assessment. In concert with our OCS technology platform and OCS Connect™ app, which enables TransMedics and transplant clinicians to efficiently track, coordinate & communicate resource logistics for donor organs procured and maintained on OCS™, TMDX launched its National OCS™ Program (NOP) in 2022: 16 regional hubs across the U.S. staffed by a dispersed workforce of experienced, on-staff OCS Perfusion Specialists & Cardiothoracic and Abdominal Donor Procurement Surgeons. These resources are mobilized on-demand via our own dedicated ground & aviation transportation logistics network, to retrieve and deliver allocated donor organs from anywhere in the U.S. - aiding U.S. Transplant Centers in bidding farewell to the time & distance limitations of cold storage & expand the pool of viable donor organs for their transplant recipients.