Quality Engineer

4 weeks ago

Los Angeles, United States Kelly Science, Engineering, Technology & Telecom Full time

Kelly Science, Engineering, Technology and Telecom

a managed solution provider and business unit of Kelly Services, is currently seeking

Design Quality Engineers

for a long-term engagement at one of our

Global Medical Device Manufacturing

clients located in

Santa Clara, CA

.

This role is a full-time, fully benefited position. As a Kelly SETT employee you will be eligible for 50% paid Medical & Dental, 401K and a variety of other benefits to choose from. You will also be eligible for paid time off, including holiday, vacation, and sick/personal time. All Kelly employees in this group receive annual performance reviews.

Robotics & Digital Solutions

client is a global leader in surgery with products and solutions found in almost every operating room around the world. Our Client has made significant contributions to surgery for more than 100 years from creating the first sutures to revolutionizing surgery with minimally invasive procedures. Continuing dedication to Shaping the Future of Surgery is built on their commitment to help address the world's most pressing healthcare issues and improve and save more lives. Through their surgical technologies and solutions including robotics, digital solutions, sutures, staplers, energy devices, trocars and hemostats and their commitment to treating serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact.

Responsibilities: Design Quality engineers Purpose - is to hire quality engineers to help support the sub-system quality engineering team Design verification protocols/reports, Summary report Support review of

NPD

verification protocols/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 dFMEA for the sub-systems Support cross-functional collaboration on key quality processes such as defect tracking/resolution, test execution Support review

of build protocol / build report, DHR and configuration change

and its 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 Requirements: Bachelor's degree preferred but Associate degree is acceptable Minimum of

3

-

5 years of design quality engineering and NPD Experience in a

medical device manufacturing environment GD&T knowledge (Preferred) 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.

For immediate consideration, please apply online. This position is recruited for by a remote Kelly office and not your local Kelly branch. No sponsorship is available at this time. (no OPT, C2C or H1B Visa)

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