Quality Engineer Lazio

Quality Engineer
Roma
Lazio, Lazio

Cosmo IMD is a division of the Cosmo Pharmaceutical group focusing on medical devices integrating artificial intelligence. Cosmo IMD has developed in recent years unrivaled expertise in multiple aspects related to the AI MedTech business, such as medical device Hardware and Software design, healthcare Artificial Intelligence development, medical data harvesting, clinical development, scientific production, and regulatory expertise in the US and worldwide. Cosmo IMD team is manufacturing GI Genius, the world's first real-time artificial intelligence medical device that is globally distributed by Medtronic. We are looking for a Quality Engineer that will be supporting development and production of Intelligent Medical Devices integrating artificial intelligence.

The main activities will be:Ensure that the AI software design team develops the product according to Operating ProceduresDevelopment and management of AI software technical documentationAI Software Verification & Validation;With focus on:Drafting/revising operating procedures related to the management of AI products lifecycle, in cooperation with QA and RA roles. Drafting/revising protocols for testing, analysis, and V&V activities, in cooperation with design team and relevant stakeholders. Documentation management and review: archiving, maintaining, a updating AI product documentation according to operating procedures. Ensuring compliance of the AI product during the R&D phase, in cooperation with the design team and relevant stakeholders. Supporting design transfer and training activities to relevant stakeholders. CAPA management: supporting non-conformance management, complaint handling and root cause analysis;Supporting activities on bugfix and cybersecurity management. Supporting QA and RA roles during audit and post-audit activities made by certification bodies.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE3+ Experience in the role (highly desirable);Life science or Engineering education;Knowledge of ISO 13485, IEC 62304, and Regulation (EU) 2017/745 (MDR) Excellent English proficiency;Excellent written and verbal communication skills. PREFERRED QUALIFICATIONSKnowledge of ISO/IEC 42001;Knowledge of 21 CFR 820;Knowledge of 21 CFR part 11;Ability to write and review all project related Documentation (FRS, SRS, SDS, HRS, HDS, etc.

)Experience on programming languages (Pyton, C++…)Experience with Linux environment;Physical RequirementsExpected travel is 30%(AI1) We support equal opportunities, without any discrimination;The research complies with Legislative Decree 198/2006