• Quality Engineer III

    Location US-CA-Hercules
    Requisition ID
    2018-7459
    # of Openings
    1
    Category
    Engineering
  • Overview

    Bio-Rad is looking for a Quality Engineer III.

    Responsibilities

    • Oversee CAPA program including leading CAPA Review Board meetings, reporting CAPA process metrics and working with CAPA owners to plan and document investigations, action implementation and effectiveness verification on time and according to procedure.
    • Advise, coach and mentor cross-functional teams with the implementation of appropriate root cause analysis techniques.
    • Present CAPAs during external audits and Quality Review Board Meetings as requested.
    • Analyze quality monitoring data sources and apply statistical techniques to ensure that recommendations for the initiation of new CAPA are based on valid statistical methods.
    • Work effectively with all levels of management to ensure CAPA action plans can be supported and that costs/resources needed to implement the plan are available.
    • Perform and document escalated customer complaint investigations, performs root cause analysis and develops corrective and preventive actions.
    • Works with customers to provide required technical support and information regarding the investigation.
    • Lead post-market Risk Management activities such as documenting risk assessments, updating risk management files and compiling post-market surveillance reports.
    • Evaluate and improve QMS procedures and training materials as required.
    • Support other quality and compliance activities as required including supporting audits and inspections.
    • Help to drive and foster a quality environment and mindset throughout the business.
    • Other duties as assigned.

    Qualifications

    • Bachelor’s degree or equivalent in a related technical discipline.
    • 5+ years’ experience or equivalent combination of education and experience.
    • Full knowledge of and application of principles and theories of quality engineering.
    • Thorough understanding of ISO 13485 and GMP regulations is preferred.
    • Quality Engineering, Six Sigma Green or Black Belt Certification preferred.
    • Working knowledge of the device/drug/biotech manufacturing process.
    • Skilled in statistical methods, statistical process control and sampling plans.
    • Experience working with Power BI and/or Minitab is preferred.
    • Understanding of risk management regulations, principles and application.
    • Communication, technical, and computer skills.
    • Coordination, tact and team work.

     

    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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