Quality Assurance Specialist

6 days ago


Durham, North Carolina, United States MILLENNIUMSOFT Full time
Job Title: Staff Quality Engineer

Location: Durham, NC

Duration: 9+ Months Contract

Total Hours/week: 40.00

The Millenniumsoft company is seeking a highly skilled Staff Quality Engineer to support the Quality team at our Durham, NC R&D facility. The successful candidate will ensure that 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 role will involve retrieving historical documentation from various locations, as well as developing documents to supplement the DHF when original documentation is no longer retrievable.

The Staff Quality Engineer will work under the direction of the Quality Team Lead and will be responsible for reviewing current DHF files to identify gaps, reviewing related documentation for addition to the DHF, creating quality records/documentation to supplement the DHF, and updating DHF indices and hard copy files, as appropriate.

The ideal candidate will have a Bachelor's Degree and experience in Design Control/Quality Assurance. Proficiency in Microsoft Office Suite products and excellent verbal and written communication skills are also essential. The salary range for this position is $90,000 - $110,000 per year, depending on experience.



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