Staff Quality Engineer

Position : Staff Quality Engineer 

Location : Durham, NC

Duration : 9+ Months Contract

Total Hours/week :40.00

Job Summary:

The associate 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.

Duties and Responsibilities:

• 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

Minimum Education / Experience:

• Bachelor’s Degree
• Experience in Design Control / Quality Assurance

Preferred Education / Experience:

• 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