Documentation Control Coordinator (Contract)

Job DescriptionThis 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 platformManage document lifecycle activities: creation, review, approval, distribution, revision, and archivalEnsure documents meet internal formatting standards and regulatory requirementsMaintain accurate records of controlled documents and change historyMonitor compliance with document control policies and escalate discrepanciesCollaborate with Quality, Regulatory, R&D, and Operations teams to streamline documentation processesInternal reporting for various company system metricsthe goalScanning of Quality DocumentationHelp to maintain training records within the document management systemPerform other TransMedics job-related tasks and duties, as assignedManagement ResponsibilitiesThis position manages the following positions on a daily basis.This position will not have management responsibilities. PHYSICAL ATTRIBUTESOffice environmentMust be able to lift up to 30lbsMinimum QualificationsMinimum of 3 - 5 years’ experience in Documentation Control role.High School DiplomaFamiliarity with eQMS platforms and document management systemsWorking knowledge of FDA 21 CFR Part 820, Part 11, ISO 13485, and EU MDR RequirementsStrong attention to detail and organizational skillsExcellent communication and interpersonal abilitiesProficiency in Microsoft Office Suite and PDF editing toolsPreferred QualificationsMedical Device experience preferred.Experience with eQMS implementation or migration projectsSome knowledge of validation and change control processesAbility 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 BenefitMedical with Health Reimbursement Account through Blue Cross/Blue Shield of MADentalVisionHealthcare Flexible Spending AccountDependent Care Flexible Spending AccountShort Term DisabilityLong Term Disability401K PlanPet insuranceEmployee Stock Purchase PlanTransMedics 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.