Sr. Engineer (Complaints)
Orange County Metro Area, CA
Life Sciences Industry
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
- 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.