• Own the day-to-day operation and continuous maintenance of Tucuvi's Quality Management System, ensuring compliance with ISO 13485 and the EU Medical Device Regulation (MDR). • Ensure our system is not only maintained but continuously improved as our product and organization evolve. • Document every process, control changes, and ensure all requirements are met. • Immerse in Tucuvi's QMS, its structure, documentation, current processes, and the regulatory framework. • Independently own key QMS processes: drafting and updating SOPs, coordinating supplier evaluations, and supporting internal audits. • Lead QMS-related activities end-to-end: from audit preparation and software validation reporting to deployment control and HR registry management. • Propose process improvements and contribute to the ongoing evolution of our quality culture across the company.