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 & 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%


Email us attaching your CV, portfolio and a motivational letter