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Sr. Engineer (Complaints)

Orange County Metro Area, CA

Posted: 05/15/2019 Job Type: Engineering Job Number: JN -052019-24899
Sr. Engineer (Complaints)
Life Sciences Industry
Irvine, CA


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 complaint evaluation reports for review and approvals.
  • Process the approved reports through our system.
  • Global Regulatory Authority Requests need MS office, QMS
  • Assess complaint data and metrics to respond to global regulatory authorities requests
  • Draft response for review and approvals
Other projects and tasks
  • Process improvement projects
  • Drafting tech summaries for approvals
  • Bachelor's degree in Engineering or Scientific field is required plus a minimum of 2 years of applicable experience; OR Master s degree in Engineering or Scientific field plus applicable internship experience.
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