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 documentsEnsure easy and efficient retrieval of documentsResponsible 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 maintenanceIssue 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 environmentMINIMUM QUALIFICATIONS
Minimum of 5 years' experience in Documentation Control role.Bachelor's Degree or equivalent combination of education and experiencePREFERRED QUALIFICATIONS
Excellent interpersonal, verbal and written communication skillsAbility to interface with a variety of people and be able to work as part of a teamExceptional proof reading and quality control skillsExperience working in a fast-paced environment as part of a cross-functional teamDemonstrated track record working with limited direction to produce high quality workProven ability to provide logical, in-depth analysis of a problem or situationOrganizational and communication skills enabling accurate and detailed change order processingMedical Device experience preferred.Familiarity with and MES systemLabel software experience preferredEmployee Benefit :
Medical with Health Reimbursement Account through Blue Cross / Blue Shield of MA
Dental
Vision
Healthcare Flexible Spending Account
Dependent Care Flexible Spending Account
Short Term Disability
Long Term Disability
401K Plan
Pet insurance
Employee Stock Purchase Plan
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.