BSI Group Technical Reviewer (Medical Device Audits) in Denver, Colorado

We 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. The position reports to the Director, Regulatory Affairs & Certification and also supports the technical management team, including Scheme Managers where required.

Essential Responsibilities

  • Complete technical/certification reviews within accreditation requirements. Ensure quality/integrity of reviews by following departmental procedures, calibration communications and/or set guidelines.

  • Liaison with the Technical Director 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.

We seek someone who meets all of the following criteria:

  • Bachelor’s Degree or Higher (or equivalent work experience)

  • General knowledge of medical device industry

  • Minimum 2 years experience working within a Certification Body environment or equivalent/comparable experience

  • Previous audit or industry experience highly preferred

  • Have integrity, ensuring that business is conducted in an ethical manner

  • Have commercial focus, understanding customers’ needs and adding value

  • Pass ANAB accredited Lead Auditor Course

  • Pass required BSI Tests of Understanding as defined by global and regional management

  • 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

  • Strong communication skills both with internal BSI personnel and customers

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.

External Company Name: British Standards Institution, The

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