• QA Auditor - Medical Device (IVD)

    Location(s) US-CA-San Diego
    Category
    Healthcare
    Contract Type
    Perm Full-Time
  • About the Role

    BSI is seeking a qualified ISO/13845 Quality Assurance Auditor.  The individual will be responsible for delivering BSI’s audit services to assigned clients in accordance with all BSI, scheme and regulatory requirements to assure timely, cost effective service delivery that assures satisfaction of our customer needs.  The ideal candidate must have knowledge of ISO 13485, CMDCAS and CE MARK and at least 2 years of “hands on” medical device manufacturing experience.

     

    The ideal candidate will need to have IVD product experience, including some manufacturing experience – with a focus on reagents, reagent products, calibrators and controls as well as IVD instruments and meters.

     

    Essential Responsibilities:

    • Analyze quality systems and assess ISO 13485 and CE Marking.
    • Responsible for attending any required training and following all procedures/processes/policies within BSI for management of clients, management of a home based office, use of BSI equipment and communication both internal and external to the organization.
    • Responsible for following the training plan developed by the AVP in order to reach assessor status and then Lead Assessor.
    • Participate in additional training based on future business needs.
    • Responsible for managing a portfolio of assigned clients based on location and a match of qualifications and client contract requirements.
    • Responsible for contacting clients and scheduling the visits, planning the assessments, making travel plans, conducting the assessments and reporting and managing the results.
    • Responsible for monitoring the client accounts to ensure that records, PointGlobal information, visit cycle, invoicing and other related matters are properly dealt with to assure client satisfaction is maintained.
    • Responsible for leading teams, when necessary, and mentoring and coaching new or inexperienced colleagues as needed to meet the business needs.
    • Any other assignments as needed to meet assessment delivery business objectives.

    About You

    We seek someone who meets all of the following criteria:

    • Can deliver and strive for superior performance, and who can achieve challenging objectives
    • Are proactive with people and can lead by example
    • Can demonstrate passion for the business and can inspire others
    • Have integrity, ensuring that business is conducted in an ethical manner
    • Have commercial focus, understanding customers’ needs and adding value
    • College degree AA or higher (or equivalent certification or work experience)
    • This position requires a minimum of 80% travel to and from clients.  This includes both land (car) and air travel.

    About BSI

    Our ambition is to be recognized and valued globally as a best-in-class company; a client-driven, efficiently-run, growing business. BSI has come a long way since being founded in 1901. Today, we’re a global business services organization, respected world over for the development of standards; assessment of management systems; testing and certification of products and services; providing software solutions; and the delivery of training courses. We offer diverse career paths from auditing to sales, product development to finance, and from IT to marketing.

    With Over 3,300 employees’ working with over 80,000 clients in 172 countries it means that career opportunities are vast. BSI challenges mediocrity and complacency to help embed excellence into the way people and products work. That means showing businesses how to improve performance, reduce risk and achieve sustainable growth.

    Our Vision: “Making excellence a habit”, it describes our way forward and our aspiration each day.
    Our Mission: “To help organizations embed excellence”, and states our shared purpose.
    Our Values: “Integrity – Continual improvement – Inclusivity”, guide us in the way we work and help us deliver our Vision and Mission.

    What we offer:
    BSI offers a competitive salary, group-sponsored health and dental, short-term and long-term disability, a company-matched 401k plan, company paid life insurance, 11 paid holidays and 4 weeks paid time off.

    BSI is an Equal Opportunity Employer and we are committed to diversity.#LI-DS1

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