Senior Quality Engineer

3 days ago


Sunnyvale, California, United States Intuitive Surgical Full time
Job Description

Primary Function of Position The Staff Quality Engineer supports product development from concept through commercialization and will serve as the core team member for the cross-functional product development team. Staff Quality engineer will provide expertise and guidance to the team on design control and risk management, Design for Reliability and Manufacturing, product Development Life Cycle, and Process Validation. In addition, this position will play an effective role to ensure that the developed products meet quality standards consistent with Intuitive' s quality processes, while meeting all external design control and regulatory requirements.

Essential Job Duties

  • Engage and manage multi-level and multi-discipline project work teams
  • Develops and implement projects to achieve targets and tracks progress against schedules; and communicates status to management
  • Provide support and expertise in the implementation and enforcement of GMP, ISO and FDA requirements
  • High Level of Proficiency with pFMEAs, Test Method Validations, Root Cause, CAPAs, Non-Conformance Management, and Process Validation
  • Proficiency with advanced data analysis tools and statistical methods (i.e., ANOVA, DOE, etc.)
  • Provide statistical support and analytical problem solving for manufacturing, technical services, and product development to identify root cause of problems
  • Experience with computerized systems, such as SAP, Trackwise, Agile, etc.
  • Experience in product design changes, manufacturing changes, supplier changes and the associated requirements to execute such changes
  • Outstanding organizational, communication, presentation, and interpersonal skill
  • Solid contributor to the planning and execution of design controls, risk management, and design verification/validation for new products
  • Ensure reliable and scalable Designs to transferred to manufacturing by supporting Design for Reliability and Manufacturing activities.
  • Support Regulatory Affairs with creating submissions and responding to submission questions.
  • Support internal and external audits, including preparation and direct interaction with auditors.


  • Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of Position:As Intuitive's da Vinci Surgical System becomes adopted by an increasing population of hospitals, surgeons, and patients, we are building a focused team to drive reliability, quality, and safety to ever-better levels. This focus applies to product in use, product in manufacturing, and product in design. Help us...


  • Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of Position:Intuitive Surgical designs and manufactures highly complex surgical systems including cameras, instruments, and accessories for use in surgery. We are looking for a proven quality functional person to support the projects associated with the development of next generation innovation products.Senior Quality Engineer...


  • Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of Position:Intuitive Surgical designs and manufactures highly complex surgical systems including cameras, instruments, and accessories for use in surgery. We are looking for a strong quality functional leader to support the projects associated with the development of next generation innovation products.Senior Quality Engineer...


  • Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of Position:Intuitive Surgical designs and manufactures highly complex surgical systems including cameras, instruments, and accessories for use in surgery. We are looking for a strong quality functional leader to support the projects associated with the development of next generation innovation products.Senior Quality Engineer...


  • Sunnyvale, California, United States Danaher Full time

    At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world's most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and...


  • Sunnyvale, California, United States Danaher Full time

    At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world's most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and...


  • Sunnyvale, California, United States Intuitive Full time

    Company Description At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team,...


  • Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of PositionThis person manages the Quality Engineering group within the Single Port Business Unit and is responsible for maintaining and advocating product quality, leads an organization that is equipped to reach across the company acting as emissaries for the Product Quality mission.Roles & ResponsibilitiesLeads New Product...

  • Care Quality Engineer

    2 weeks ago


    Sunnyvale, California, United States Apple Full time

    AppleCare Quality Engineer Sunnyvale,California,United States Support and Service AppleCare Service Quality & Technology is a global organization that is seeking an exceptional quality engineer who will be involved in all aspects of product and service quality for Apples products. The preferred candidate must be a strong leader with exceptional technical...


  • Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of PositionThis position will require being onsite in a set schedule weekly and will report into Senior Manager – Product Quality Digital & CSA. The primary responsibility of this person is to represent PQ as a self-directed quality oversight on the GxP Computerized Systems Validation efforts globally across Intuitive sites...


  • Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of PositionThis position will require being onsite in a set schedule weekly and will report into Senior Manager – Product Quality Digital & CSA. The primary responsibility of this person is to represent PQ as a self-directed quality oversight on the GxP Computerized Systems Validation efforts globally across Intuitive sites...


  • Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of Position:The Core Technologies Engineering (CTE) group within Intuitive has an immediate opening for a dedicated C/C++ Code Quality expert to join our team in Sunnyvale, CA. The ideal candidate will possess deep knowledge of C/C++ development standards and extensive experience improving code quality. This role requires...


  • Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of Position: This person leads and functionally manages the Quality Engineering group. You will interface with leaders including VPs and Directors throughout the design, operations, regulatory, IT, marketing and service areas of Intuitive Surgical. Quality Engineering is primarily responsible for measuring quality and helping...


  • Sunnyvale, California, United States tapwage Full time

    This role is ideal for a motivated applicant that is self-driven, enjoys working in a fast-paced development environment, and has a strong quality background.Supplier Quality Engineer for FPC/FPCA Responsibilities The Supplier Quality Engineer will be in charge of the FPC/PCB process/quality control, FPCA quality control, and the entire supply chain...


  • Sunnyvale, California, United States tapwage Full time

    This role is ideal for a motivated applicant that is self-driven, enjoys working in a fast-paced development environment, and has a strong quality background.Supplier Quality Engineer for FPC/FPCA Responsibilities The Supplier Quality Engineer will be in charge of the FPC/PCB process/quality control, FPCA quality control, and the entire supply chain...


  • Sunnyvale, California, United States Intuitive Surgical, Inc. Full time

    Company Description At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team,...


  • Sunnyvale, California, United States Intuitive Surgical, Inc. Full time

    Company Description At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team,...

  • Quality Engineer 3

    4 weeks ago


    Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of Position:As Intuitive's da Vinci Surgical System becomes adopted by an increasing population of hospitals, surgeons, and patients, we are building a focused team to drive reliability, quality, and safety to ever-better levels. This focus applies to product in use, product in manufacturing, and product in design. Help us...

  • Quality Engineer 3

    2 months ago


    Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of Position:As Intuitive's da Vinci Surgical System becomes adopted by an increasing population of hospitals, surgeons, and patients, we are building a focused team to drive reliability, quality, and safety to ever-better levels. This focus applies to product in use, product in manufacturing, and product in design. Help us...


  • Sunnyvale, California, United States Amazon Services LLC Full time

    The Amazon Lab126 team is looking for a Software Quality Assurance Engineer to drive world class quality in the software platform that makes a one of a kind experience today, and will enable exciting new capabilities tomorrow.A successful candidate will be obsessed with quality improvement and automating tests for regression and new features....