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Technical Reviewer - Medical Device QMS Audits

Company: BSI America
Location: Raleigh
Posted on: May 20, 2019

Job Description:

About the RoleWe are seeking a homebased Technical Reviewer with a background in quality management and medical devices (i.e. ISO 13485 and MDSAP) to review third-party audit findings and undertake certification decisions in accordance with BSI procedures, accreditation and where required technical scheme requirements. Occasional travel may be required for training purposes, but will constitute less than 10% of the role.

Essential Responsibilities:



  • Complete technical/certification reviews within accreditation requirements. Ensure quality/integrity of reviews by following departmental procedures, calibration communications and/or set guidelines.
  • Advise on accreditation requirements per ISO/IEC 17021.
  • Liaison with the Global QMS Manager and/or Technical Scheme Managers sector specific requirements to ensure compliance with sector requirements.
  • Generate and follow up on corrections identified during the review process.
  • Collect/analyze reports/statistics/data for the management team.
  • Provide support to scheme managers in calibration and/or data collection related to product specific performance.

    #LI-MSFITZAbout YouA Technical Reviewer at BSI strives for superior performance with a passion for quality and compliance. He/she must be efficient and collaborative while working from home. The individual must have a commercial focus, understanding customer needs and the importance of adding value. The Technical Reviewer has integrity, ensuring that business is conducted in an ethical manner. This person must be proficient in Microsoft Office and able to quickly learn new systems.

    Required Education/Experience:



    • Bachelor's degree or higher (or equivalent work experience) in related field.
    • Knowledge of BSI procedures or accreditation body requirements for certification.
    • Must be able to pass ANAB accredited ISO 13485 Lead Auditor Course.
    • Must be able to pass required BSI Tests of Understanding as defined by global and regional management.
    • Scheme specific external credentials as defined by the scheme in which reviews will be undertaken.
    • General knowledge of the Medical Device/Healthcare industry.
    • Good understanding of the overall registration and certification processes.
    • Understanding of the constituent elements of what constitutes an identified and valid nonconformity.
    • Know how to undertake root cause analysis.
    • Awareness of MDSAP requirements for certificate issue.
    • Minimum 2 years experience working within a Certification Body environment or equivalent/comparable experience.

      Preferred Education/Experience:



      • Previous ISO 13485 audit or industry experience highly preferred.
      • SAP experience preferred.


        About BSIOur 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 around 4,000 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: "To be the global business improvement partner of choice."

        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.

Keywords: BSI America, Raleigh , Technical Reviewer - Medical Device QMS Audits, Accounting, Auditing , Raleigh, North Carolina

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