Quality Engineer

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Quality Engineer

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    Quality Engineer
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    Direct Hire
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The DAVIS Companies has partnered with a leader in the medical device industry by securing a Quality Engineer to join their team. This position will be responsible for providing technical quality engineering support for customers, processes and systems, including driving continuous improvement activities.

Quality Engineer Responsibilities: 

  • Guide CAPA team to root cause and determine appropriate verification of effectiveness strategies.
  • Perform QA technical review and approval of documentation for products.
  • Report Quality data for management reviews and other Quality reporting (CAPA, NCMR, Compliant, as well as others.).
  • Support product and process risk control measures and files (FMECA, pFMEA).

Skills and Experience of Quality Engineer:

  • Four-year degree in technical field or equivalent combination of education & experience.
  • Training in statistics & experience using Minitab Software preferred.
  • 2-4 years' experience in regulated industry (FDA/ISO) preferred.
  • Computer proficiency.
  • Ability to read, analyze and interpret common technical procedures.
  • Knowledge in working with Root Cause Analysis,using quality tools such as Fish Bone Diagramming, Flow Charting, 8D and Value Streaming.
  • Knowledge or training pertaining to FDA and ISO regulations

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