Quality Engineer

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Job Description

Position Summary:


Quality Engineer will be responsible for leading and mentoring team members in using measurement equipment to measure the dimensions of the product, visual inspections incoming Inspections.


Key Activities:


  • Performs root cause analysis and implements preventive and corrective actions.
  • Performs test and validation activities.
  • Developing and conducting process validation (IQ, OQ and PQ).
  • Performing capability studies.
  • Use and programming of OGP SmartScope preferred.
  • Ability to run Coordinate Measuring Machine (CMM) for inspections.
  • PC DMIS CMM programming a plus.


Required Qualification:


  • Experience leading teams.
  • Experience within the medical device industry.
  • Experience working within an ISO 13485 quality system.
  • Experience with quality audits.
  • Experience with Statistical Process Control (SPC), Design of Experiment (D.O.E.), High, Low, Nominal measurements.
  • Experience with all aspects regarding capability studies.
  • Experience developing quality and risk documentation (Process Flow Charts, FMEAs, Control Plans, Work Instructions, etc.).
  • Gage R&R.
  • Knowledge of reading and interpreting specification drawings.
  • Working experience and knowledge of GD&T.
  • Experience working within an injection molding environment.
  • Willing to do what it takes to get the job done right.
  • Clearly communicates in English, both written and spoken.
  • Detail oriented.
  • Able to make good decisions based on facts.
  • ELF Vision System experience a plus.
  • FDA Regulatory experience a plus.

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Posted: Jul 27, 2020

Type: Full Time

Category: Quality