Documentation Control Intern

Job Description:

POSITION SUMMARY

TransMedics is transforming organ transplantation through the Organ Care System (OCS), an advanced medical technology platform. Operating within a highly regulated global environment, our Quality team ensures compliance with GMP, GDP, and international regulatory standards. Documentation control is critical to maintaining product safety, traceability, and regulatory readiness.

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.

Hours: 30–40 hours per week.

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 40lbs

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. 

Maximize your potential at TransMedics, Inc.

www.TransMedics.com 

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.