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- Irvine, CA
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Engineer II (Quality/Complaints Experience)
Apex Systems • Irvine, CA
Posted 5 days ago
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Global medical device company in Irvine is seeking Quality Engineers to join their growing team!
- 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 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
- Bachelor's degree in Engineering or Scientific field is required plus a minimum of 2 years of applicable experience (med device preferred)
Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178