Norbert Nehéz Email & Phone Number

Nyírbátor

As a Test Method Specialist, I take part in the design, validation, implementation and maintenance of test methods used for product release, process validation and design verification of medical devices at volume manufacturing sites, complying with ISO13485 and FDA regulations. As part of a corporate team supporting various manufacturing sites around the world, the responsibilities include :-designing test methods, including setting equipment/chemical requirements, testing robustness and suitability through design of experiments and statistical analysis, and creating instructions for test methods-setting requirements for test equipment qualification-measurement system analysis (Gauge R&R, capability testing, statistical hypothesis testing, linearity studies, bias investigations, etc.), validation of test methods-review and approval of documentation relating to test method instructions, test equipment qualifications and validations-giving input to R&D, and taking part in the handover process for innovation projects, related to test methods and test equipment-supporting process validation with test method competencies-conducting trainings for colleagues in production about test methods and procedures-improvement and development of existing test methods-maintaining of test method instructions, ensuring change control-taking part in the maintenance, update and improvement of corporate procedures-taking part in internal and external audits

Nyírbátor, Hungary

Working in a team as a process validation engineer, my duties included creating and maintaining risk assessments relating to manufacturing equipment compliant with ISO 13485, creating,reviewing, approving and executing IQ, OQ and PQ protocols with a risk-based approach, including the creation of GMP compliant documentation, managing stakeholders related to the projects, and performing statistical analysis for verifying process performance . Took part in planning and executing retrospective software (computerized system) validations, ensuring compliance, based on the GAMP5 approach. I was also responsible for being the one-point contact to HQ regarding test methodologies, and for executing test equipment qualifications and executing test method validations.

Százhalombatta

Working at the R&D department, as part of my thesis work, I took part in developing an on-line analytical solution for industrial applications, assessed the method's viability for the factory's needs, and optimized the statistical models needed.

Nyíregyháza

As an intern, my responsibilities included inspecting the quality of the raw rubber mixtures used and stored, managing the stored raw materials by the results of these measurements, and also keeping the inventory up to date.

Master Of Science (M.Sc.), Chemical Engineering, With Honours

Bachelor Of Science (Bsc), Chemical Engineering, With Honours