TransMedics
Documentation Control Coordinator (Contract)
Andover, MA · Contract
Sponsorship not specifiedDetected 30 days ago
Patient CareFDA RegulatoryMedical DevicesCommunicationOrganizational SkillsMicrosoft Office
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16Unrated
Cap-exempt (no lottery)0
Sponsors this role0
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
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About the role
- Job Description: This role is contract position.
- TransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide.
Responsibilities
- 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
- Help to maintain training records within the document management system
- Perform other TransMedics job-related tasks and duties, as assigned
Requirements
- 5 years' experience in Documentation Control role.
- Working knowledge of FDA 21 CFR Part 820, Part 11, ISO 13485, and EU MDR Requirements
- Proficiency in Microsoft Office Suite and PDF editing tools
- Must be able to lift up to 30lbs
Nice to have
- Experience with eQMS implementation or migration projects
- Some knowledge of validation and change control processes
- Every Organ Wasted is a Life Not Saved.
Company info
- Our mission is to help save more patients' lives by increasing access to viable donor organs for those who are awaiting an organ transplant.
- 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.
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This listing is sourced directly from TransMedics's careers page and normalized into a canonical job model.