• Quality Assurance Analyst (Quality Engineer II)

    Location US-CA-Hercules
    Requisition ID
    # of Openings
  • Overview

    Bio-Rad is looking for a Quality Engineer. 




    • Responsible for maintaining the 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.
    • Responsible for ensuring all required information for a complaint file is obtained and properly documented.
    • Evaluates all information to ensure appropriate analysis, investigation, and root cause is documented prior to complaint closure.
    • Ensure adequate information is received to warrant timely reporting, investigation, and closure of product complaints.
    • Responsible for analyzing product quality information (case escalations, trend information, etc.).  Provide technical and analytical support to subsidiaries and internal functional areas.


    • Product Complaint Handling, Post Market Surveillance, knowledge of the regulation (Medical Device Reporting), GMP (QSR/ISO13485) and Risk Management (ISO14971) regulations and systems.
    • Knowledge and understanding of CAPA and associated investigation tools.
    • Knowledge/experience in HPLC (diabetes) testing, newborn screening, and/or drug screening.
    • 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.
    • Understands basic principles, theories, concepts and techniques related to customer complaints.  
    • Basic computer skills required, including MS Windows, MS Word, MS Excel, MS PowerPoint, Minitab.
    • Knowledge/experience with Salesforce complaint management system is 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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