Remote QA/RA Officer – EU MDR for Robotic Surgery

Surgerii Robotics

Netherlands

Hybrid

EUR 45,000 - 65,000

Full time

7 days ago
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Job summary

Surgerii Robotics, a high‑tech medical device company, seeks a Junior QA/RA Officer to support the EU QMS by handling complaints, CAPA, RMA records, and document control.

Based in the Netherlands with remote‑first work and occasional travel to Amsterdam, you will log and triage EU hospital complaints, track CAPA investigations with the Beijing team, and ensure traceability across RMA, repair, and service records in compliance with ISO 13485 and EU MDR.

Qualifications

  • Bachelor's or master's in life sciences or related technical field.
  • Minimum 2+ years QA/RA in medical devices.
  • Knowledge of EU MDR 2017/745 and ISO 13485:2016.
  • Experience with complaint handling, CAPA, and document control.
  • English fluency; Dutch/German a plus.

Responsibilities

  • Own daily EU QMS operations including document control.
  • Log, triage, and assess product complaints from EU hospitals.
  • Maintain complaint register and ensure traceability across records.
  • Coordinate CAPA investigations with Beijing team and verify effectiveness.
  • Manage RMA/repair records in the Netherlands and related releases.
  • Ensure QMS documents are issued, revised, distributed and archived.

Skills

QA/RA experience
EU MDR knowledge
Complaint handling
CAPA
Document control

Education

BSc/MSc Life Sciences or related

Job description

Surgerii Robotics, a high‑tech medical device company, seeks a Junior QA/RA Officer to support the EU QMS by handling complaints, CAPA, RMA records, and document control.

Based in the Netherlands with remote‑first work and occasional travel to Amsterdam, you will log and triage EU hospital complaints, track CAPA investigations with the Beijing team, and ensure traceability across RMA, repair, and service records in compliance with ISO 13485 and EU MDR.

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