Quality Engineer
2 weeks ago
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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