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Role Description

We are looking for someone to join the QA/RA team and take hands-on ownership of our Quality Management System (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!

Your main mission will be to own the day-to-day operation and continuous maintenance of Tucuvi's QMS, 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.

What to expect during your first months with us:

• During your first month: Immerse yourself in Tucuvi's QMS, its structure, documentation, current processes, and the regulatory framework underpinning our SaMD certification.
• By the end of month three: Independently own key QMS processes: drafting and updating SOPs, coordinating supplier evaluations, and supporting internal audits.
• After 6-12 months: Be a key pillar of the QARA team, leading QMS-related activities end-to-end.

Responsibilities

• QMS documentation maintenance: Draft, update and release SOPs; manage document control and ensure proper communication.
• Supplier management: Lead periodic evaluation of QMS-related suppliers; maintain compliance with ISO 13485 requirements.
• Deployment control: Support and coordinate the quality control process for new Work Unit (WU) deployments.
• Audit participation: Actively participate in internal and external audits; prepare evidence and coordinate teams.
• Regulatory compliance monitoring: Conduct periodic reviews of the regulatory compliance plan; ensure alignment with evolving requirements.
• QMS software validation: Generate periodic software validation reports for QMS-related tools.
• CAPA management: Manage the full lifecycle of QMS-related Corrective and Preventive Actions (CAPAs).
• Data analysis & reporting: Analyse quality data and prepare ad-hoc reports to support management reviews.
• Product & tools QA testing: Conduct manual QA testing of products and internal tools when required.

Qualifications

• 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.
• Ability to write clear, precise quality documentation.
• Fluent in Spanish and English (written and spoken).
• Proactive, autonomous, and structured mindset.

Requirements

• Experience with Software as a Medical Device (SaMD) or software validation in regulated environments.
• 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.

Benefits

• Fix and variable salary with flexible benefits through Cobee.
• 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.
• Budget for training and personal development.
• A laptop (Mac) + the equipment that you need.
• The possibility to join a team of good and ambitious people where you can create a real impact on people's lives.