QARA Specialist

🕒 Março 11

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Tucuvi

SiteLinkedInTodas as Vagas

11 - 50 funcionários

🤖 Inteligência Artificial

☁️ SaaS

Healthcare • Artificial Intelligence • SaaS

A Tucuvi é uma empresa de tecnologia na área da saúde que se especializa em soluções de IA para melhorar o cuidado com os pacientes. Seu produto principal, o LOLA®, é um agente de voz de IA clinicamente validado, projetado para melhorar a eficiência operacional das equipes de saúde enquanto garante o monitoramento de qualidade para os pacientes. A Tucuvi colabora com organizações de saúde de alto nível para implementar sua plataforma de voz clínica de IA em várias aplicações, incluindo monitoramento de sintomas ambulatoriais e acompanhamento, melhorando assim o engajamento do paciente e a qualidade do cuidado fornecido.

Descrição

• 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.

🎯 Requisitos

• 1–3 years of experience in a QA/RA or Quality Management role in the medical device or health tech sector. • Solid working knowledge of ISO 13485 and the EU Medical Device Regulation (MDR). • Hands-on experience maintaining a QMS: document control, SOPs, CAPAs, supplier management, and audit support. • Strong organizational skills and attention to detail, with the ability to manage multiple processes simultaneously in a fast-paced environment. • Ability to write clear, precise quality documentation and translate regulatory requirements into practical processes. • Fluent in Spanish and English (written and spoken). • Proactive, autonomous, and structured mindset, someone who takes ownership and follows through.

🏖️ Benefícios

• Remote work in an async environment. • Flexible working hours. • Teambuildings (at least two per year). • 23 days per year + your birthday + 6 local and regional holidays added to your calendar. • Budget for training and personal development. • A laptop (Mac) + the equipment that you need.