QARA Specialist

Tucuvi

Madrid, Spain (Remote)RemoteCompetitiveAdded yesterday

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QARA Specialist

Tucuvi·Madrid, Spain (Remote)

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QARA Specialist

Tucuvi

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At Tucuvi, we help healthcare organizations ensure every patient receives timely high-quality care, augmenting clinical teams with AI.

Our clinical-grade AI Care Management platform automates and orchestrates high-volume workflows end to end, combining autonomous AI agents-including LOLA, our Voice Clinical Agent-with workflow logic, escalation, documentation, and seamless integration into existing health system infrastructure. Built for trust and clinical reality, Tucuvi is the first Class IIb Software as a Medical Device (SaMD)-approved AI platform for Voice AI driven patient management.

Today, we support 50+ care pathways across 60+ healthcare organizations, delivering up to 80% automation of nursing workflows, >90% patient engagement, and improved clinical outcomes. We recently raised $20M in Series A funding to scale across Europe and the US.

CONTEXT

We have built the first Clinical AI Agent certified as Software as a Medical Device (SaMD) under the EU Medical Device Regulation (MDR), with CE marking and ISO 13485 certification. As we scale our platform across Europe and the US, maintaining a rigorous and well-maintained Quality Management System is non-negotiable. Our QA/RA (Quality Assurance & Regulatory Affairs) team is central to ensuring our technology meets the highest standards of safety, quality, and regulatory compliance.

We are looking for someone to join the team and take hands-on ownership of our QMS operations. This is an ideal role for someone with solid QMS experience in the medical device space who wants to grow within a fast-moving healthtech company and take real ownership of quality processes from day one!

WHAT YOU'LL DO

Your main mission will be to 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). You'll ensure our system is not only maintained but continuously improved as our product and organization evolve.

You will be the backbone of our QMS, the person who ensures every process is documented, every change is controlled, and every requirement is met.

What to expect during your first months with us

During your first month:

You'll immerse yourself in Tucuvi's QMS: its structure, documentation, current processes, and the regulatory framework underpinning our SaMD certification. You'll get familiar with our tools, understand how QMS processes integrate with product development and deployment, and start identifying areas where you can immediately add value.

By the end of month three:

You'll be independently owning key QMS processes: drafting and updating SOPs, coordinating supplier evaluations, and supporting internal audits. You'll have a solid understanding of our regulatory obligations under MDR and will be actively contributing to CAPA management and compliance monitoring.

After 6-12 months:

You'll be a key pillar of the QARA team, leading QMS-related activities end-to-end: from audit preparation and software validation reporting to deployment control and HR registry management. You'll proactively flag risks, propose process improvements, and contribute to the ongoing evolution of our quality culture across the company.

RESPONSIBILITIES

QMS documentation maintenance: Draft, update and release SOPs in response to new regulatory requirements or operational needs; manage document control and ensure proper communication and reading confirmation across the team.
Supplier management: Lead periodic evaluation of QMS-related suppliers, maintaining up-to-date records and compliance with ISO 13485 requirements.
Deployment control: Support and coordinate the quality control process for new Work Unit (WU) deployments, ensuring proper validation and documentation.
Audit participation: Actively participate in internal and external audits, preparing evidence, coordinating teams, and following up on findings.
Regulatory compliance monitoring: Conduct periodic reviews of the regulatory compliance plan, flagging updates and ensuring alignment with evolving MDR and ISO 13485 requirements.
QMS software validation: Generate periodic software validation reports for QMS-related tools in compliance with regulatory standards.
CAPA management: Manage the full lifecycle of QMS-related Corrective and Preventive Actions (CAPAs), from identification to closure and effectiveness review.
Data analysis & reporting: Analyse quality data and prepare ad-hoc reports to support management reviews and decision-making.
Product & tools QA testing: Conduct manual QA testing of products and internal tools when required, ensuring quality standards are met before deployment.

WITH WHOM YOU WILL WORK

We are a remote-first company, but here, no one works alone.

You'll work closely with the QARA team, as well as cross-functional teams including Product, Engineering, and Customer Success, to keep quality embedded in everything we do. You'll also coordinate with external stakeholders such as auditors, notified bodies, and suppliers.

Meet part of the team you'll be working more closely to: Clara Soler, QARA & AI Governance Director, Sandra Peris, QARA Specialist and Alejandro García, Security & Compliance Specialist.

REQUIREMENTS

You'll succeed in this role if you have:

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.

Nice to have ✚

Experience with Software as a Medical Device (SaMD) or software validation in regulated environments, as well as FDA.
Familiarity with post-market surveillance, technical documentation, or regulatory submissions.
Exposure to quality management tools or QMS software platforms.
Background in biomedical, industrial, or telecommunications engineering.
Knowledge of ISO 27001 or other compliance frameworks.