An influential medical technology company based in Irvine, CA are searching for a Quality Engineer II to work in their THV Quality Engineering, Global Product Surveillance (GPS) team.
This team is responsible for leading and performing critical engineering investigations on globally reported complaints for returned/non-returned devices. This is an initial 6-month contract position with the opportunity to extend. This a 100% on-site role based in their Irvine facility.
Pay rate: $52 hourly
Some Key Responsibilities:
- Investigate complex manufacturing product quality and compliance issues reported from the field, analyse results, determine root cause/probable cause, and initiate and review reports.
- Perform hands-on device investigation using visual, dimensional, and test equipment to determine root cause.
- Participate in escalation tasks and activities, including Project Risk Assessments (PRA) and Corrective/Preventive action(s) - CAPAs, SCARs, as determination by investigation.
Some Key Requirements:
- Bachelor's Degree or equivalent in Engineering or Scientific field, 2 years' experience related work experience required; or Master's Degree or equivalent in Engineering or Scientific field, 1 year experience including either industry or industry/education required.
- Experience in medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment preferred.
- Complaints investigation or failure investigation experience - preferred.
- Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
- Knowledge of and adherence to Quality systems
- Must be able to work in a team environment, including the ability to manage project stakeholders
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