• Statistical Quality Engineer (Quality Engineer IV)

    Location US-CA-Pleasanton
    Requisition ID
    # of Openings
    Quality & Regulatory
  • Overview

    Bio-Rad is looking for a Quality Engineer IV.


    • Primarily responsible for the review and evaluation of V+V plans/protocols/reports to meet applicable ISO 13485 and FDA QSR requirements.
    • Assist other functional groups in developing and writing the documentation as needed.
    • This position may be required to fulfill those functions for groups outside of the Digital Biology Group as appropriate for other quality system requirements.
    • Primarily responsible for statistical analysis of customer complaints using appropriate statistical methods/analysis.
    • This position may be required to fulfill this function for groups outside of the Digital Biology Group as appropriate for other quality system requirements.
    • Secondary responsibilities include supporting the maintenance of quality processes to ensure that all product complaints are processed in accordance with established company procedures and standards, including but not limited to assessing risk, investigating root cause, implementing effective long-term corrective actions to prevent recurrence, and potentially reportable events.
    • Secondary responsibilities include supporting the evaluation of all information to ensure appropriate analysis, investigation, and root cause is documented prior to complaint closure.
    • Secondary responsibilities include analyzing product complaint information and support for providing metrics (case escalations, product quality issues, trend information, etc.).


    • Must have knowledge of statistics, use of statistical methods/analysis.
    • Must have bachelor’s or master’s degree in an appropriate science/technical field that can be applied to ddPCR.
    • 3+ years’ experience or equivalent combination of education and experience working in an FDA and/or ISO 13485 regulated environment.
    • Detail oriented with excellent organizational and project management skills.
    • Excellent verbal and written communication, problem solving, analytical skills required.
    • Critical thinking skills, ability to multitask in a high-pace environment with fast deadlines, and ability to work well under pressure.
    • Contribute individually but work as a team.
    • Effective communication with various departments.
    • Intermediate computer skills required, including MS Windows, MS Word, MS Excel (use of pivot tables/charts) and MS PowerPoint.
    • Knowledge/experience with Salesforce complaint management systems a big plus.


    About Bio-Rad:


    Bio-Rad is a global leader providing a broad array of clinical diagnostics and life science research products. With a team of more than 7,800 employees and a global network of operations serving our customers, we help people live longer, healthier lives.


    Bio-Rad was founded over six decades ago and has continued to provide the healthcare industry with innovative and useful products that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better results.


    EEO/AA Employer/Veterans/Disabled/Race/Ethnicity/Gender/Age


    Agency Non-Solicitation:


    Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.


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