Quality Engineer

MRPCButler, WI
12h

About The Position

Position Description SUMMARY: The Quality Engineer oversees the validation process, the QMS system and participates in the Internal Quality Audits. Position reports to the QA Manager

Requirements

  • Requires education that is generally found in Bachelors degree in engineering or equivalent combination of education and experience.
  • Requires three to five years of previous experience in quality engineering to become familiar with the use of testing devices, techniques, and test procedures.
  • Requires two years medical device industry experience.
  • Proficiency in MS Word, Excel, Access, and Minitab.

Responsibilities

  • Perform operation and programming of OGP Smartscope.
  • Write and maintain FDA level validation protocols and reports.
  • Support quality planning activities on new and existing programs.
  • Investigate customer quality issues and requests.
  • Interpret and implement ISO9000/13485 and FDA standards.
  • Assist in preforming internal audits.
  • Maintain Calibration System.
  • Perform other duties as assigned.
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