Job Description:

RESPONSIBILITIES: 

This position is responsible for, but not limited to, the following:

• Develop, implement, and maintain comprehensive record retention systems, policies and procedures
  • Implement electronic file system 
  • Ensure accuracy, quality and integrity of all company documents
  • Ensure easy and efficient retrieval of documents
• Responsible for execution of all Document Change Orders in support of manufacturing, engineering and other departments, as necessary in accordance with policies and procedures.
• Provide training for all employees on the Document Change Order, training process and QMS.
• DMR maintenance
• Issue Lab Notebooks.
• Maintain all Training Files for the company.
• Review and update documents for maintenance and quality control with being audit ready as the goal.
• Perform other TransMedics 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

MINIMUM QUALIFICATIONS 

• Minimum of 5 years’ experience in Documentation Control role.
• Bachelor’s Degree or equivalent combination of education and experience

PREFERRED QUALIFICATIONS 

• Excellent interpersonal, verbal and written communication skills
• Ability to interface with a variety of people and be able to work as part of a team 
• Exceptional proof reading and quality control skills
• Experience working in a fast-paced environment as part of a cross-functional team
• Demonstrated track record working with limited direction to produce high quality work
• Proven ability to provide logical, in-depth analysis of a problem or situation
• Organizational and communication skills enabling accurate and detailed change order processing
• Medical Device experience preferred.
• Familiarity with and MES system
• Label software experience preferred

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.