Quality Management Systems Expert

2 months ago

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

About the Role

We are seeking a highly skilled Medical Devices Auditor to join our EIMEA Medical Devices Auditing Team. As a Medical Devices Auditor, you will be responsible for ensuring the quality and safety of medical devices, particularly those with high-risk software.

Key Responsibilities

  • Conduct audits of medical devices to ensure compliance with ISO 13485 and other relevant standards
  • Assess the technical expertise of medical devices, including research and design, validation, testing, and servicing
  • Work with cross-functional teams to identify and mitigate risks associated with high-risk software
  • Develop and implement effective quality management systems to ensure patient safety and timely market access

Requirements

  • Technical expertise in high-risk software medical devices, including research and design, validation, testing, and servicing
  • Working experience of quality management systems and understanding of ISO standards, particularly ISO 13485
  • Excellent communication and interpersonal skills
  • Ability to work in a fast-paced environment and prioritize multiple tasks

What We Offer

  • 27 days annual leave, paid sick leave, and bank holidays
  • Health insurance, life insurance, and pension plan with company contribution
  • Car allowance (dependent on role), income protection, paid maternity leave, paid paternity leave, paid parental leave, adoption leave, compassionate leave, and paid bereavement leave
  • Learning and development opportunities, and a wide range of flexible benefits

About BSI

BSI is a global partner for 86,000 companies and organizations in over 193 countries, offering development, auditing, certification, and training services. We are a Notified body with a history spanning over a century and 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
  • Agile
  • Collaborative

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