Quality Engineer

Purpose

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%