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QA Auditor - Medical Device (Active)

at bsi.

Posted: 9/29/2019
Job Reference #: 11177
Keywords: compliance

Job Description

  • Location(s)US-OH-Toledo
    Contract Type
    Perm Full-Time
    Hiring Manager
    Danielle Snyder
  • The Opportunity

    BSI is hiring a Quality Assurance (QA) Auditor – Medical Devices to join our Operations Delivery team. This role is remote with frequent domestic travel to client sites.

    Our QA Auditors (known internally as Client Managers) are the MVPs of the Assurance business. Utilizing their past experience in engineering, design, or quality control of medical devices, combined with rigorous BSI training, they conduct audits for clients to ensure products meet international standards and are go-to-market ready. The ideal candidate will need experience working with medical devices in the following categories: Active, IVD, Organic or Medical Device Software.

    They travel from client to client, utilizing their knowledge and expertise while continually learning on the job – getting better at their craft every day. This position involves extensive travel (nearly 100%), which means it is ideal for people who do not have ongoing weeknight commitments or obligations that will not allow them to spend several nights a week away from home. If you enjoy building relationships with customers, exploring new places, and delving deeper into the inner workings of companies, then this could be a very exciting job opportunity for you.

    The QA Auditor position is a full-time salaried role with a comprehensive benefits package.

    Essential Responsibilities:

    • Deliver BSI’s third-party 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. Analyze quality systems and assess ISO 13485 and CE Marking.
    • Manage a portfolio of assigned clients based on geographic location and a match of qualifications and client contract requirements. Client management includes contacting them to schedule the visit, planning the assessment, making appropriate travel plans, conducting assessments, completing reports, and managing results.
    • Participate in professional development and training opportunities to achieve necessary certifications and statuses

    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.


    About You

    This client-facing role is designed for someone who is highly knowledgeable, passionate about helping companies improve, and committed to continual learning. Please carefully review the qualifications listed below and apply if you meet the criteria.

    Qualifications and Education Requirements:

    • Undergraduate degree in engineering, science, or other related field
    • Knowledge of CMDCAS and CE Mark
    • 5-8 years of quality management experience in medical device/healthcare industry
    • 2+ years of “hands on” medical device manufacturing experience in one or more of the following:
      • Research and development, manufacturing, or service
      • Application of the device technology and its use in health care services and with patients
      • Testing the devices concerned for compliance with relevant national or international standards
      • Performance testing, evaluation studies or clinical trials of the devices.
    • Experience with medical devices within one of the following areas:
      • Active Devices
      • In-Vitro Diagnostic (IVD)
      • Organic
      • Medical Device Software
    • Ability to travel at least 80% of the time (car and/or plane)

    Preferred Skills and Experience:

    • Certified ISO/13845 Quality Assurance Auditor highly preferred