• Quality Manager I

    Location US-WA-Woodinville
    Requisition ID
    # of Openings
    Quality & Regulatory
  • Overview

    The Quality Manager I position supervises and leads staff responsible for Quality Engineering functions, as assigned.   This includes management and development of staff, communication of organizational and departmental goals, coaching and annual performance assessments. This position is responsible for Quality Engineering activities including management of Quality Boards and associated activities as required to maintain compliance with FDA, ISO and other industry standards.


    Compliance to ISO 13485:2016, ISO 62366:2015, ISO 14971:2012 and MDSAP requirements.  This position will be responsible for the direct and indirect management of Quality Engineers and Quality System Specialists.  They will also be responsible for providing support for QMS functions and Quality Boards.


    • Bachelor's degree in a related field.
    • 5+ years of job related experience with supervisory experience and an emphasis on working in a cGMP/QSR/ISO regulated industry. 
    • Preferred candidates should have experience working under FDA regulations and ISO standards. 
    • Experience supervising/managing a quality systems program in a regulated environment preferred. 
    • Experience with the development, manufacture or support for in vitro diagnostics or biological product testing highly desirable. 
    • Experience with managing product and process risk files preferred. 
    • Lead ISO auditor certification preferred. 
    • Certified Quality Engineer, Quality Manager, Six Sigma Green or Black Belt preferred.


    What's in it for you?:

    Competitive pay and great benefits including medical, dental, vision, 401K, and more!
    Opportunities for growth and training. 
    Stability of a profitable 60+ year old company. 
    Great work environment. 

    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

    To all recruitment agencies: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Staffing 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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