Software Project Manager - Auditor

In order to further develop the Medical Division, we are looking for an Auditor with knowledge in the field of active medical devices.

The role represents an exciting opportunity for an experienced professional who will be in charge of the evaluation of new medical technologies under development, with a specific focus in the field of artificial intelligence and software. In addition to managing and coordinating project development, the role includes the analysis of technical documentation and audit activities.

Job Description

The resource will be responsible for the correct and complete management of assigned projects:

• It deals with the evaluation of technical documentation of SW and AI
• Carries out inspections in client companies with reference to 9001/13485 and for Directive 93/42/EEC and Regulation 2017/745
• It follows the certification path of companies
• He is technically and managerially responsible for all activities related to the assigned customers
• Collaborates, to the extent of its competence, in the drafting of tenders
• Prepares reports on inspection activities
• Works, as far as relevant, on the development of the internal Quality System

• 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
• Entrapreneurship and organisational skills
• Analytical capacity
• Excellent interpersonal skills
• Good knowledge of English
• Italian mother tongue or fluent