Reports. Test method validation, test fixture design review/qualification. Review regression analysis and ensure that impacts are clearly justified. Support Installation qualification of non-product software, test equipment. Support risk management activities specifically review of d. FMEA for the sub-systems. Support cross-functional collaboration on key quality process such as defect tracking/resolution, test execution, etc. Support review of build protocol / build report, DHR and configuratio... more details
Kelly® Engineering is hiring a Design Quality Engineer for an opportunity onsite in Santa Clara, California. If you’re passionate about driving tomorrow’s healthcare and medical innovations and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Design Quality Engineer (Development Quality Engineering) Contract: 6 months (potential extension) Santa Clara, California (onsite) Pay Rate: $50/hr W2
Responsibilities:
Seeking quality engineers to help support the sub-system quality engineering team.
Support review of design verification related deliverables for the program.
Test method validation, test fixture design review/qualification.
Review regression analysis and ensure that impacts are clearly justified.
Support Installation qualification of non-product software, test equipment.
Support risk management activities specifically review of dFMEA for the sub-systems.
Support cross-functional collaboration on key quality process such as defect tracking/resolution, test execution, etc.
Support review of build protocol / build report, DHR and configuration change and it’s impact on Design Verification reports.
Review design changes including mechanical and electrical drawings.
Support creation and review of Inspection plan for components and sub-assemblies.
Support review of Design Control deliverables.
Qualifications required:
Must have experience in design quality engineering and new product development experience.
GD&T knowledge (preferred).
Experience in medical device industry or other highly regulated field.
Previous work experience engaging in a team-based environment.
Experience with medical electrical-mechanical systems.
Knowledge of FDA requirements for design control of medical devices.
Understanding of Risk Management process per ISO 14971.
Minimum of a bachelor’s degree.
What happens next: Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert technology recruiters will have access to your profile, making your opportunities limitless.
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