QA/RA Officer

This role will take ownership of the daily execution of the EU QMS—including complaint handling, CAPA, RMA/repair records, and document control.

Key Responsibilities

· Receive, log, triage, and perform initial vigilance assessments for product complaints originating from EU hospitals (Munich, Vall d'Hebron, and future sites).

· Maintain the complaint register, monitor timelines, and ensure full traceability across complaint, RMA, and field service records.

· Initiate, document, and track CAPA processes; coordinate root-cause investigations with the Beijing team and verify CAPA effectiveness.

· Manage the RMA/repair master records in the Netherlands as the single source of truth (covering intake, wipe-down, repair, QC, release, or end-of-life).

· Generate RMA numbers and process returns dispatched directly from hospitals.

· Manage the controlled QMS document stack (issuance, revision, distribution, and archiving); ensure form control, training records, and retention periods comply with ISO 13485 and EU MDR.

· Execute the day-to-day operations of the EU QMS and contribute to its continuous improvement.

Required Qualifications

· Bachelor's or Master's degree in Life Sciences, Biomedical/Mechanical Engineering, or a related technical/regulatory field.

· Minimum 2+ years of QA/RA experience in the medical device industry (preferably within an EU MDR regulated environment).

· Working knowledge of EU MDR 2017/745 (specifically Articles 10, 13, 14, 15, and 87) and ISO 13485:2016.

· Hands-on experience in complaint handling, CAPA, and document control processes.

· Fluency in English (working language) – proficiency in Dutch and/or German is a strong advantage.

· Must legally hold the right to work in the Netherlands.

Preferred Skills & Experience

· Experience with active medical devices, robotic systems, or capital equipment repair/servicing.

· Knowledge of ISO 14971 risk management, vigilance reporting, EUDAMED, and UDI frameworks.

· Experience with Notified Body audits is plus.

Work Structure & Additional Information

· Work Model: Primarily Remote + occasional hybrid (travel to the Amsterdam office and EU repair facility as operational needs dictate—e.g., for RMA inspections, audits, and team coordination).

· Reporting Line: Reports directly to the Head of EU Regulatory Affairs & PRRC.