QARA Specialist

🕒 March 11

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Tucuvi

WebsiteLinkedInAll Job Openings

11 - 50 employees

🤖 Artificial Intelligence

☁️ SaaS

Healthcare • Artificial Intelligence • SaaS

Tucuvi is a healthcare technology company that specializes in AI-powered solutions to improve patient care. Their flagship product, LOLA®, is a clinically validated voice AI agent designed to enhance the operational efficiency of healthcare teams while ensuring quality monitoring for patients. Tucuvi collaborates with top-tier healthcare organizations to deploy its AI Clinical Voice platform for various applications, including outpatient symptom monitoring and follow-up care, thereby improving patient engagement and the quality of care delivered.

📋 Description

• 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.

🎯 Requirements

• 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.

🏖️ Benefits

• 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.