Job Description: Engineer II (Quality/Complaints Experience)
Location: Irvine, CA
Position Type: 12+ Months
- 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 systems
- Global Regulatory Authority Requests – need MS office, QMS
- Assess complaint data and metrics to respond to global regulatory authority requests
- Draft response for review and approvals
- Other projects and tasks
- Process improvement projects
- Drafting tech summaries for approvals
- May support CAPAs and PRAs
- 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.
- 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.