Quality Engineer Lazio

Quality Engineer
Roma
Lazio, Lazio

Join the Quality Engineering Team to support development and production of Intelligent Medical Devices Work Location: Rome – Italy – Viale Ostiense 131/L Key Responsibilities Software and Hardware Verification & Validation Development and management of technical documentation Ensure that the design team develops the product according to Operating Procedures Draft and/or revise procedures and checklists for production (e. g. , assembly, software installation, product release…) Draft and revise protocol for end-of-line testing Label management and control Documentation management and review: archiving, maintaining a file for checking produced serials Design transfer and training activities CAPA management: non-conformance management and compliant, root cause analisys Qualification – Required Knowledge, Skills and Abilities Knowledge of IEC/EN 60601-1 and IEC/EN 60601-1-2 Knowledge of IEC 62304 Knowledge of 2017/745(MDR) and 21 CFR 820 Knowledge of 21 CFR part 11 Ability to write and review all project related Documentation (FRS, SRS, SDS, HRS, HDS, etc. )

Familiarity with medical software development and software development processes in compliance with regulations.

Minimum Required Education and Experience 3+ Experience in the role (highly desirable) Life science or Engineering education Knowledge of ISO 9001, ISO 13485, 93/42/CEE (MDD) Good English Level (writing and speaking) Physical Requirements Expected travel is 20% Apply Email us attaching your CV, portfolio and a motivational letter #J-18808-Ljbffr