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Quality Assurance Specialist
Ref No.: 18-03336
Location: Durham, North Carolina
Bachelor's Degree Experience in Design Control / Quality Assurance Additional skills required Working experience with DHF creation and/or maintenance in the medical device industry Proficiency in Microsoft Office Suite products Exhibit excellent attention to detail with a high degree of accuracy Ability to work independently Excellent verbal and written communication and organizational abilities 

The Design Quality Specialist will support the Quality team at the Client Durham, NC R&D facility to ensure that the design history files (DHF) for identified products meet all corporate policies, government regulations and medical device industry standards for Design Controls. The position will primarily work with Quality Assurance to ensure comprehensive Design History Files exist for Women's Health and Cancer products maintained at the Durham, NC R&D facility. The work will include retrieval of historical documentation that may be in a variety of locations, as well as the need to develop documents to supplement the DHF when original documentation is no longer retrievable. The position will work under the direction of the Staff Quality Engineer. • Review current DHF files to identify gaps • Review related documentation for addition to the DHF • Create quality records / documentation to supplement the DHF, as appropriate • Update DHF indices and hard copy files, as appropriate • Exhibit an excellent attention to detail with a high degree of accuracy, and the ability to work independently, and in team situations. • Interact with other functions as needed