Tucuvi

QARA Specialist

Tucuvi

full-time

Posted on:

Location Type: Remote

Location: United States

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Job Level

Junior

About the role

  • 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.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
ISO 13485EU Medical Device Regulation (MDR)Quality Management System (QMS)SOPsCAPAsdocument controlsupplier managementaudit supportprocess improvementsoftware validation
Soft Skills
organizational skillsattention to detailability to manage multiple processesclear writingproactive mindsetautonomousstructured mindsetownershipfollow-through