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Product Quality Engineer

Santa Clara, California 95054

Category: Professional Job Number: 16922

Voca has an immediate opening available for a Product Quality Engineer in Santa Clara, CA! Interested candidates will email current resume to Chad Miller at cmiller@myvoca.com and call 952-303-8107.
 

Position Details 

Job Description:

  • Responsible for failure analysis for medical devices (Mitra clip) and complaint investigation into the device.
  • Will do analysis on the physical device, collaborate with other techs/engineers to see if there’s anything they can identify with the physical device that would have caused the complaint.
  • Serves as the primary contact for engineering support of In-Process Inspectors.
  • Supports production efforts and process improvements (trend analysis, process validation, SPC).
  • Coordinates In-Process MRB activities.
  • Supports Quality Systems (perform audits, SOP improvement, training, CAPA investigations).
  • Ensures from the Quality prospective the transfer of new products from R&D to Production.
  • Supports Statistical Techniques and SPC interpretation.
  • Presents PPR and Management Review.
  • Will be working in a biohazard environment.

Qualifications

  • Bachelor of Science or higher degree in ME, IE or equivalent.
  • Mechanical or Industrial degrees are most preferred. Other engineering/science degrees are next in line. Need someone heavy on engineering side.
  • Med device experience is preferred, not looking for aerospace exp. Could be open to Pharma or Biomedical background.
  • Wants 2 years or more of failure analysis experience and CAPA experience in relation to failure recreation.


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