Expertise and projects
Quality and regulatory affairs · Oracle NetSuite · Electronic design
I connect technical requirements, business processes and digital tools. My work spans needs analysis, solution development and ongoing maintenance, combining hands-on work with the coordination of technical teams.
Below are some of my areas of expertise and projects I have worked on.
Quality and regulatory affairs
Development and maintenance of ISO 9001, EN 9100 and ISO 13485 management systems: defining processes and documentation, preparing and managing audits, handling non-conformities and corrective actions.
For medical devices, I manage testing, manuals, technical files and registration activities, coordinating documentation and communication with laboratories and relevant bodies.
The path to certification
I developed management systems and guided the company through achieving ISO 9001, EN 9100 and ISO 13485 certification. I oversee their maintenance and ongoing development, liaising with internationally recognised certification bodies.
International medical device registrations
I have managed medical device registration procedures for international markets, overseeing testing, technical documentation and communication with the bodies involved through to completion, including in particularly demanding countries such as those in Northern Europe.
Oracle NetSuite and business processes
ERP implementation and administration, process analysis, customisation and integration development. I tailor NetSuite to operational needs and maintain and enhance solutions over time.
Product configuration and quotations
I managed the implementation of Oracle NetSuite within the company and developed CPQ (Configure, Price, Quote) solutions for configuring products, calculating prices and preparing quotations. The project connects knowledge of products and their variants with the sales processes managed in the ERP.
Warehouse management: in operational use since 2022
I developed a custom solution that combines the speed and ease of use needed in day-to-day warehouse operations with the requirement to record every transaction accurately in NetSuite. The solution has been in operational use since 2022, and I maintain and update it as business needs evolve.
Integrating NetSuite with company-owned servers
To enable the company to retain control over where its files are stored, I designed and developed a connector linking NetSuite directly to servers the company already owned, without relying on external suppliers to develop the integration.
I personally handled the requirements analysis and implementation, addressing the specific technical challenges of connecting the systems. The integration has been in operational use since 2024.
I also coordinate a team of engineers working on business processes and manufacturing bills of materials, setting priorities and reviewing results.
Electronic design
I design circuit schematics and printed circuit boards (PCBs) and coordinate a team of engineers, external consultants, operators and students working on their theses. The team develops wheelchair control systems compatible with the main controllers available on the market and compliant with their interface requirements. The portfolio includes around ten products that have been on the market across Europe for several years.
Consultancy and collaboration
I provide consultancy in quality systems, medical device regulatory affairs, Oracle NetSuite and electronic design. I can contribute to a specific task or support a broader project, with agreed objectives, scope and timelines.