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    Quality Engineer - Santa Clara, United States - MyKelly

    MyKelly
    MyKelly Santa Clara, United States

    3 weeks ago

    Default job background
    Full time
    Description
    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 deliverablesRequirements:
  • 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.
  • Previous experience working at a start-up company preferred.
  • 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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