Req#: 488329

JOB DESCRIPTION

Position: Document Control Specialist

Reports to: Senior Manager, Document Control

ESSENTIAL RESPONSIBILITIES AND DUTIES INCLUDE:

• Develop, implement, and maintain comprehensive record retention systems, policies and procedures
  1. Implement electronic file system
  2. Ensure accuracy, quality and integrity of all Company documents
  3. Ensure easy and efficient retrieval of documents
  4. Ensure that obsolete documentation is removed from distribution and is appropriately archived.
• 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 and training process.
• Organize and maintain Design History Files from inception through archival.
• Enter data into various Microsoft Access databases.
• Maintain Master Part Number, Item Master and Document Index.
• 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.

EXPERIENCE/SKILLS:

• Minimum of 5 years’ experience in Documentation Control role.
• Medical Device experience a must!
• A working knowledge and/or experience in the following areas:

• Working knowledge of QMS / PLM systems a must!
• Experience working with various CAD files (AutoCAD, PRO-E, Orcad, SolidWorks).
• Experience working with Microsoft Office, Excel, and Adobe
• Documentation Management Software
• Experience maintaining Microsoft Access databases
• Label software experience preferred

Creation of Adobe PDF control documentation

Organizational and communication skills enabling accurate and detailed change order processing

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 with an MRP interfacing system

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

EDUCATION:

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