• Quality Engineer III

    Location US-CA-Hercules
    Requisition ID
    2018-6701
    # of Openings
    1
    Category
    Quality & Regulatory
  • Overview

    Bio-Rad is looking for a Quality Engineer III.

    Responsibilities

    • Provide technical and quality systems guidance into content of validation and qualification plans, protocols and reports.
    • Review and approve validation activities in support of manufacturing, logistics and design control processes.
    • Maintain, revise and assess multiple site Facilities Master Validation Plans.
    • Participate in and/or lead the Quality Management System Validation Review Board.
    • Participate in and/or lead various Change Control activities, including chairing change control meetings, ownership of change files, review and approval of change management plans, verification activities, etc.
    • Support risk (ISO 14971) and usability (ISO 62366) processes related to validation and change control activities.
    • Able to apply statistical methods is support of the validation and change control processes, including Statistical Process Control, Measurement Systems Analysis, and Design of Experiments.
    • Support the Post Market Surveillance, Corrective and Preventative Action (CAPA) program, complaint investigation and nonconforming product processes.
    • Evaluate and improve QMS procedures and training material as required.
    • Support other quality and compliance activities as required.
    • Other duties as assigned.

    Qualifications

    • Working knowledge of Change Control/Management, Validation and Post Market Surveillance.
    • Thorough understanding of Medical Device Reporting, cGMP, QSR, ISO-13485, ISO-14971 and ISO-62366 regulations and standards is preferred.
    • Knowledge and understanding of CAPA and associated investigation tools.
    • Understanding of statistical methods, statistical process control and sampling plans.
    • Quality Engineering, Six Sigma Green or Black Belt Certification preferred.
    • Knowledge/experience in medical device, drug or biotech manufacturing a plus.
    • 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.
    • Working knowledge of MS Word, MS Excel, MS PowerPoint, Minitab.
    • Knowledge/experience with SAP and/or Salesforce systems a 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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