Document Control Specialist

JOB DESCRIPTION

Position:          Document Control Specialist

Reports to:      Document Control Manager

Essential Responsibilities and Duties Include:

·      Develop, implement, and maintain comprehensive record retention systems, policies and procedures

o   Implement electronic file system

o   Ensure accuracy, quality and integrity of all Company documents

o   Ensure easy and efficient retrieval of documents

o   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 3-5 years experience in Documentation Control role.

·      A working knowledge and/or experience in the following areas:

·      Working knowledge of QMS systems

·      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