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Staff Quality Assurance Specialist

1 month ago

Durham, North Carolina, United States MILLENNIUMSOFT Full time

Job Title: Staff Quality Engineer



Job Summary:



The MillenniumSoft team 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.



Key Responsibilities:



  • Review current DHF files to identify gaps and ensure comprehensive Design History Files exist for Women's Health and Cancer products maintained at the Durham, NC R&D facility.
  • Retrieve historical documentation from various locations and develop documents to supplement the DHF when original documentation is no longer retrievable.
  • Collaborate with Quality Assurance to ensure that all Design History Files meet the required standards.
  • 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 to ensure seamless execution of tasks.


Requirements:



  • Bachelor's Degree in a relevant field.
  • Experience in Design Control / Quality Assurance, preferably in the medical device industry.
  • Proficiency in Microsoft Office Suite products.
  • Excellent verbal and written communication and organizational abilities.


Preferred Qualifications:



  • Working experience with DHF creation and/or maintenance in the medical device industry.
  • Excellent attention to detail with a high degree of accuracy.
  • Ability to work independently and as part of a team.
  • Excellent verbal and written communication and organizational abilities.