The Documentation Control Intern will gain hands-on experience in document management principles within a regulated medical device environment. This role supports the development, maintenance, and continuous improvement of document control processes to ensure compliance with global regulatory requirements.
This internship is ideal for students interested in Quality Systems, Regulatory Affairs, Operations, or process-driven environments.
RESPONSIBILITIES:
This position is responsible for, but not limited to, the following:
Document Management Support
Assist with processing and maintaining GMP and GDP documentation
Support document routing, review, approval, and archival processes
Ensure documents meet formatting, version control, and traceability requirements
Maintain accurate records within document management systems
Compliance & Process Improvement
Support adherence to global regulatory and quality system requirements
Assist in identifying opportunities to improve document workflows
Help maintain document tracking logs and status reports
Participate in audits or audit preparation activities as needed
Operational & Administrative Support
Assist with filing, scanning, and organizing controlled documents
Support database updates and data entry tasks
Manage multiple priorities in a fast-paced environment
Lift and move document boxes or materials (up to 40 lbs) when required
What You’ll Learn
GMP (Good Manufacturing Practice) and GDP (Good Documentation Practice) principles
The structure of quality systems in medical device companies
Regulatory compliance fundamentals
Document lifecycle management
How traceability and accuracy protect product integrity
Why This Internship Stands Out
You will gain foundational experience in regulated documentation systems that are critical to medical device manufacturing and global compliance. This role provides strong exposure to Quality and Regulatory operations within a life-saving technology company.
MANAGEMENT RESPONSIBILITIES
This position does not have direct reports.
PHYSICAL ATTRIBUTES
General office environment where there is a significant amount of time at a desk, working on computers and reviewing documents. This requires the ability to sit for extended periods. They also may need to stand for meetings or when moving around the office.
MINIMUM QUALIFICATIONS
High School Senior, College Freshman, Sophomore, or Junior
Strong attention to detail and organizational skills
Proficiency in Microsoft Office (Word, Excel, Outlook)
Database experience preferred
Ability to multi-task in a fast-paced environment
Strong written and verbal communication skills
Ability to lift up to 40 lbs
PREFERRED QUALIFICATIONS
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 expandtheir 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.
Maximize your potential at TransMedics, Inc.
Employee Benefit:
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.
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, and clinical care.
With more than 25 years of commitment to excellence and innovation, TransMedics is at the forefront of advancing the field of organ transplantation. Our innovative Organ Care System (OCS™) technology is the only FDA-approved technology for lung, heart and liver transplant indications in the U.S., enabling the optimization and assessment of donor organs outside the human body and replacing a decades-old outdated standard of care: static cold storage (ice). Combined with our National OCS Program (NOP), a nationwide team of clinical experts, 24/7 logistics support, and the first-of-its-kind dedicated air & ground transport logistics network, we are enabling transplant centers to expand their search criteria for viable organ donors and grow overall transplant volumes in the U.S.
www.TransMedics.com
