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Medical Device Auditor

1 mese fa


Milano, Lombardia, Italia Luminary Group A tempo pieno

Job Description

The Luminary Group is seeking a highly skilled Medical Device Auditor to join our team. As a key member of our team, you will be responsible for the evaluation of new medical technologies under development, with a specific focus in the field of artificial intelligence and software.

Key Responsibilities

  • Evaluate technical documentation of SW and AI
  • Carry out inspections in client companies with reference to 9001/13485 and for Directive 93/42/EEC and Regulation 2017/745
  • Follow the certification path of companies
  • Be technically and managerially responsible for all activities related to the assigned customers
  • Collaborate in the drafting of tenders
  • Prepare reports on inspection activities
  • Work on the development of the internal Quality System

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