Quality Engineer

Hebron, KY

Quality Engineer
Pay: $40-$46/hr
Duration: 12-month contract with potential to extend or convert based on performance and budget. 
100% Onsite in Hebron, KY


Responsible for, but not limited to:
  • Write and conduct IOQ and spreadsheet validations.
  • Complete PQ, TMV, AQ validations.
  • Develop, maintain, monitor, and audit quality management system and protocols, including systems automation, processes, and procedures that ensure compliance with regulations and standards.


Requirements: 
  • Bachelor’s degree in engineering (mechanical, electrical, chemical, bioengineering, or a related area) is required. 
  • 5+ years of experience in the medical device industry is required. 
  • Familiarity with CFR 21 Part 820 and ISO13485.
  • Proficiency in Microsoft Excel and a good working knowledge of computer programming and systems is required. 
  • Knowledge of PQ, TMV, AQ, NPSV validations is preferred but not required. 



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