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:
· 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 maintaining Microsoft Access databases
· Label software experience preferred
· 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
Makeda Lord TransMedics
Job Type: Full-time
Benefits:
Schedule:
Ability to commute/relocate:
Experience:
Work Location: One location
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