Quality Engineer II

3 weeks ago


Irvine, United States Hydrogen Group Full time

Summary:

A leading Medical Device company are actively seeking a motivated candidate to fill their Engineer II role. This is an initial 6-month contract role with opportunity to extend/ convert to FTE. This is an onsite role is based out of Irvine, CA. Salary ranges between $44-49/hour depending on experience.

Requirements:

  • Bachelor's and/or Master’s Degree in Engineering.
  • 2+ years’ experience Engineering (i.e., Quality, Post-Market Regulatory Affairs) work experience in Medical Device industry.
  • Preferred software’s; MATLAB, CAD (SolidWorks), MiniTab, eQMS.
  • Experience performing customer complaints investigations i.e., root causes of the nonconformities, establishing corrective and preventive actions etc.

Responsibilities:

  • Perform customer complaints investigations, providing detailed analysis of the process and the data; determine root causes of the nonconformities in order to establish corrective and preventive actions.
  • Execute complaint investigations multifunctional approach and issues addressed in a systematic, methodical manner.
  • Work closely with complaint investigation owners to resolve issues and ensure those that have passed their due dates are addressed.
  • Optimize moderately complex Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.


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