Medical Device Auditor
3 giorni fa
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
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