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Engineer II (Quality/Complaints)

Orange County Metro Area, CA

Posted: 05/14/2019 Job Type: Engineering Job Number: JN -052019-24884
Engineer II (Quality/Complaints)
Life Sciences Industry
Irvine, CA

Duties:

Complaints needs experience with 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 review complaint evaluation reports
  • 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 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 (preferably 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 Master s degree in Engineering or Scientific field plus applicable internship experience.
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