Medical Device Auditor

3 settimane fa


Milano, Lombardia, Italia Luminary Group A tempo pieno

Luminary Group is seeking a skilled Medical Device Auditor to join our team.


The ideal candidate will have knowledge in the field of active medical devices and be responsible for evaluating new medical technologies under development, with a focus on artificial intelligence and software.


Key responsibilities include:



  • Evaluating technical documentation of SW and AI
  • Conducting inspections in client companies according to 9001/13485 and Directive 93/42/EEC and Regulation 2017/745
  • Following the certification path of companies
  • Managing and coordinating project development
  • Analysis of technical documentation and audit activities

Requirements:



  • Degree in Electronic Engineering, Biomedical Engineering or equivalent
  • Knowledge of industry standards and laws - Must have experience in IEC 60601
  • Must have experience in Software and Robotics in a Medical Device industry
  • Entrepreneurship and organisational skills
  • Analytical capacity
  • Excellent interpersonal skills
  • Good knowledge of English
  • Italian mother tongue or fluent

About the Company: Luminary Group is a leading provider of innovative solutions in the medical industry. We are committed to delivering high-quality products and services that meet the highest standards of excellence.


What We Offer: A dynamic and challenging work environment, opportunities for professional growth and development, and a competitive salary and benefits package.



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