Our client located in Irvine, CA is looking for an Engineer II (Quality/Complaints Experience)
Long term contract
Pay rate $40-42 per hour
Our customer is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives.
Engineer II (Quality/Complaints Experience)
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 complaint evaluation reports for review and approvals.
Process the approved reports through company 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.
ROOT CAUSE ANALYSIS