Quality Engineer Jobs

Quality Engineer

Cosmo Intelligent Medical Devices

Location:
Italy, Rome

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Not provided

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Job Description:

Join the Quality Engineering Team to support development and production of Intelligent Medical Devices

Job Responsibility:

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

Requirements:

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.
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)

Additional Information:

Job Posted:
December 07, 2025

Work Type:

On-site work

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