Senior Quality Engineer
Masimo - Irvine, CA

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(NASDAQ: MASI) headquartered in Irvine, California, is a fast-growing and award-winning international medical technology and device company with operations spanning the globe. We develop innovative, noninvasive monitoring technologies that save, extend and improve the lives of people of all ages, in all walks of life. These revolutionary technologies are helping to solve "unsolvable" problems that have plagued the healthcare industry, while taking the pain and discomfort out of blood monitoring. For more than 20 years, innovation has been and will continue to be our passion.

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Duties and Responsibilities:

General: Provides technical leadership for all aspects of quality engineering throughout the product realization process. This position will handle multiple projects from product inception, development, through manufacture and customer use. Provides a key role to ensure product meets defined quality standards, and worldwide regulatory requirements. Supports all facility activities including design control activities, process validations and inspection and test activities.

  • Supports new product development and product manufacturing through the application of quality engineering tools. Assure conformance of systems and processes during the development, manufacture and quality control operations with respect to internal procedures, Quality System Regulations (FDA CFR 21 820), ISO 13485, Canadian Medical Device Requirements (CMDR) MDD 93/42 EEC and other applicable international standards and regulations.
  • Leads and participates in problem solving activities related to design, manufacture and inspection and test, including CAPA, NCR and supplier related issues. Interfaces with various product certifications agencies such as UL, CSA and external laboratories. Provides information to demonstrate credibility and compliance with all applicable regulations. Communicates significant issues or developments during quality inspection activities and through analysis provides plans and recommendations to the team and management for resolution.
  • Leads and participates in IQ/OQ and PQ activities, test sample size selection, test method validations, Gage R&R studies and risk management activities to assure conformance to product quality standards and applicable regulations. Develops and manages programs that monitor, predict, or regulate research and development, manufacturing, and inspection activities. This may be accomplished through the application of statistical tools such as Minitab and/or SQC pack.
  • In conjunction with the QA management, ensures robust application of the quality system by supporting the management review process, including the generation of data for CAPA, NCR, in RI and in process inspections, internal and external; audits and customer feedback activities.
  • Working with Supplier Quality Assurance s upports operations in the selection and approval and auditing of new suppliers including new product introduction and qualification.
  • Participates with regulatory compliance group in developing Risk Analysis.
  • Develop and maintain Design History Folders (DHF) for products.

  • Minimum Education:

    B.S. in Science, Engineering or equivalent combination of education and experience.

    We are proud to offer if eligible a highly competitive compensation plan with an excellent benefits package including 3 weeks vacation, stock options, 401k match, medical, dental, vision plans and much more!

    Masimo is proud to be an EEOE and we value and are committed to Diversity at every level.

    ***NO AGENCIES PLEASE*** Thank you!

    About this company
    8 reviews
    As important as the blood running through your veins is the oxygen it carries. Masimo knows that and makes tools that monitor arterial...