Quality Engineer

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 & ValidationDevelopment and management of technical documentationEnsure that the design team develops the product according to Operating ProceduresDraft and/or revise procedures and checklists for production (e.g., assembly, software installation, product release…)Draft and revise protocol for end-of-line testingLabel management and controlDocumentation management and review: archiving, maintaining a file for checking produced serialsDesign transfer and training activitiesCAPA management: non-conformance management and compliant, root cause analisysQualification – Required Knowledge, Skills and Abilities Knowledge of IEC/EN 60601-1 and IEC/EN 60601-1-2Knowledge of IEC 62304Knowledge of 2017/745(MDR) and 21 CFR 820Knowledge of 21 CFR part 11Ability 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 educationKnowledge of ISO 9001, ISO 13485, 93/42/CEE (MDD)Good English Level (writing and speaking)Physical Requirements Expected travel is 20%ApplyEmail us attaching your CV, portfolio and a motivational letter
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