Engineer II (Quality/Complaints Experience) in Irvine, CA at APEX Systems

Date Posted: 7/16/2019

Job Snapshot

  • Employee Type:
  • Location:
    Irvine, CA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:

Job Description

Job #:  969934
Duties: Complaints - need MS office, Ignite, QMS Perform complaint investigation on devices that are returned and on complaints where the device is not returned. Work in the lab to perform visual inspection, measurements (dimensional), and functional testing where appropriate to determine root cause Review manufacturing documents, data, FMEAs, SOPs, and metrics as part of the investigation Author and reviewcomplaint evaluation reports Process the approved reports through Edwards system Global Regulatory Authority Requests - need MS office, QMS Assess complaint data and metrics to respond to global regulatory authoritiy requests Draft response for review and approvals Other projects and tasks Process improvement projects Drafting tech summaries for approvals May support CAPAs and PRAs

Skills: Looking for someone that is strong in Excel (preferrably with Pivot Table experience) and strong in data analysis, running queries, creating metrics, and conducting laboratory investigations with subsequent evaluation report writing.

Education: Bachelor's degree in Engineering or Scientific field is required plus a minimum of 2 years of applicable experience; OR Masters degree in Engineering or Scientific field plus applicable internship experience.
EEO Employer
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