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.