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Caterina RussoCR
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Caterina Russo

@caterinarusso

Quality and Validation Engineer at Medi-Globe Technologies GmbH validating medical device processes, software, sterilisation, and transport.

Germany
Message

At Medi-Globe Technologies GmbH, I plan and document validations for medical device software, reprocessing, EO sterilisation, and transport in line with regulatory requirements. I also evaluate external production process validations with suppliers.

I support manufacturing process introductions and improvements, participate in audits, and prepare technical documentation for Notified Bodies. My work also includes CAPA, change management, process descriptions, and risk assessments.

At 3M Oral Care Solutions Division, I carried out process optimisation and digitalisation subprojects, supported production process analysis, and processed data for automated reports. Earlier, at Walley Design, I modelled and dimensioned valves for oil systems using SolidWorks.

Experience

Work history, roles, and key accomplishments

MG
Current

Quality and Validation Engineer

Medi-Globe Technologies GmbH

Sep 2023 - Present (3 years 2 months)

Planning, organising, and documenting validations in accordance with regulatory requirements in the medical device industry, including software, reprocessing, EO sterilisation, and transport validation. Evaluating external validations, supporting process optimisation, participating in audits, and handling CAPA and change management.

Education

Degrees, certifications, and relevant coursework

Johner Institute logoJI

Johner Institute

Internal Auditor for Medical Devices per ISO 19011, Medical Devices

2026 - 2026

Internal Auditor for Medical Devices per ISO 19011 course completed in June 2026.

QA

qtec academy

MDSAP Training, Medical Device Regulatory

2025 - 2025

MDSAP Training course completed in August 2025.

Nelson Labs logoNL

Nelson Labs

Introduction to the Validation of Sterile Medical Devices, Medical Device Validation

2024 - 2024

Introduction to the Validation of Sterile Medical Devices course completed in September 2024.

Johner Institute logoJI

Johner Institute

Computerized Systems Validation (CSV) Seminar, Computerized Systems Validation

2024 - 2024

Computerized Systems Validation (CSV) Seminar completed in March 2024.

TÜV SÜD logoTS

TÜV SÜD

Process Validation, Process Validation

2023 - 2023

Process Validation course completed in October 2023.

Technische Universität München logoTM

Technische Universität München

Master of Science, Biomedical Engineering and Medical Physics

2021 - 2023

Master of Science in Biomedical Engineering and Medical Physics. Thesis on two-grating interferometer for AXDT measurements with a robotic arm.

Comau logoCO

Comau

Robotics License, Robotics

2020 - 2020

Robotics License course completed in 2020.

Università degli Studi Guglielmo Marconi logoUM

Università degli Studi Guglielmo Marconi

Bachelor of Science, Industrial Engineering

2016 - 2020

Bachelor of Science in Industrial Engineering. Thesis on modelling of valves for industrial use with SolidWorks.

EM

European School Munich

European Baccalaureate, General Education

2010 - 2016

European Baccalaureate from the European School Munich.

Tech stack

Software and tools used professionally

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