QA/RA Officer (Netherlands)

About Surgerii Robotics

Surgerii Robotics (Beijing Surgerii Robotics Co., Ltd.) is a high‑tech medical device company dedicated to advancing minimally invasive surgery through innovative robotic technology. Founded by Dr. Kai Xu of Shanghai Jiao Tong University, the company focuses on the research, development, production, and global commercialization of laparoscopic surgical robotic systems.

Surgerii is the creator of the SHURUI Single‑port Endoscopic Surgical System (SR‑ENS‑600)—the world’s first commercially available single‑port surgical robot with snake‑like instruments. This breakthrough platform enables surgeons to perform complex minimally invasive procedures through a single incision, offering enhanced precision, dexterity, and visualization. The system is CE‑marked for urologic, gynecologic, general, and thoracoscopic laparoscopic procedures.

With headquarters and manufacturing in Beijing and an innovation center in Shanghai, Surgerii has built a strong foundation of proprietary technologies and is backed by leading investment institutions and industry partners. The company is pioneering a new era of single‑port robotic surgery and expanding its impact across multiple surgical specialties worldwide.

About the Role

We are looking for a Junior QA/RA Officer to support our Quality 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 return 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.