Auditor for High Risk Medical Devices

7 days ago


Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom BSI Full time

About the Role

We are seeking a highly skilled Medical Devices Auditor with expertise in High Risk Software to join our EIMEA Medical Devices Auditing Team. As a key member of our team, you will be responsible for ensuring patient safety while supporting timely market access for our clients' medical device products globally.

Key Responsibilities

  • Conduct audits of medical devices with high risk software to ensure compliance with ISO 13485 and other relevant standards.
  • Develop and maintain strong relationships with clients to understand their quality management systems and identify areas for improvement.
  • Collaborate with cross-functional teams to develop and implement effective auditing strategies.
  • Stay up-to-date with industry developments and regulatory requirements to ensure our clients' products meet the highest standards.

What We Offer

  • A competitive salary and benefits package, including 27 days annual leave, paid sick leave, and a pension plan with company contribution.
  • Opportunities for professional growth and development, including training and certification programs.
  • A dynamic and supportive work environment with a team of experienced professionals.
  • The chance to work with a global organization with a history spanning over a century.

About BSI

BSI is a world-leading business improvement company that helps organizations achieve excellence through standards, training, and certification. We are committed to ensuring the diversity of our workforce reflects that of our clients and the communities in which we operate.

Our Values

  • Client-centric: We put our clients at the heart of everything we do.
  • Agile: We are adaptable and responsive to changing needs.
  • Collaborative: We work together to achieve our goals.


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