Quality Manager ( Must be a resident of Beijing for compliance reasons)
Beijing
Finance & Ops – Quality Systems & Complaints /
Permanent, Full-time /
On-site
Vision RT is a fast-growing MedTech company transforming radiation therapy for cancer patients by helping make it more accurate, effective, and comfortable. The company is the inventor of, and a market leader in, Surface Guided Radiation Therapy (SGRT). This technology uses advanced 3D cameras to track surface data, providing enhanced guidance across every step of the radiotherapy workflow.
Vision RT’s SGRT solutions are in 24 out of the 25 “Best Hospitals for Cancer,” as tracked by US News & World Report.
The company is recognised as one of Britain’s fastest-growing private tech companies, as featured in the 2025 Sunday Times 100 Tech list. Vision RT is also a recipient of the 2024 King’s Award for Enterprise, the UK’s most prestigious accolade for business excellence.
With around 300 employees globally and offices in the UK, Poland, and the USA, Vision RT operates independently as part of the Danish company William Demant Invest A/S, one of the world’s largest investors in healthcare companies. Employees benefit from the security and reach of being part of a large global enterprise, combined with the agility and innovation of a startup.
Vision RT is a company with strong values, a clear mission, and a bright future. It is an exciting and rewarding organisation in which to work.
About role:
The Quality Manager China is responsible for leading quality management and regulatory compliance for Vision RT’s Class III medical device manufacturing site in Beijing. The role ensures full compliance with applicable regulatory requirements—including China NMPA regulations and ISO 13485—while serving as the Quality Management Representative for the China organisation
***Must be a resident of Beijing for compliance reasons***
Key Responsibilities
- Lead Quality Assurance and Quality Control activities for Class III medical device manufacture at Vision RT’s Beijing factory.
- Act as the Management Representative and head of the Quality Management function within the QMS.
- Maintain, oversee, and continuously improve the ISO 13485‑compliant QMS, ensuring alignment with NMPA requirements for Class III devices.
- Oversee in‑process and final product quality control activities.
- Ensure robust CAPA, non‑conforming product management, complaint handling, and process risk management processes.
- Lead internal audits, supplier audits, and external audits, including NMPA inspections.
- Support regulatory interactions with the NMPA, including engagement with regulatory consulting partners for domestic and import device licensing.
- Assist with post‑market surveillance activities, including complaint handling, adverse event reporting, and field actions.
- Deliver QMS and regulatory compliance training for China-based staff.
- Collaborate cross‑functionally with UK headquarters and global teams.
- National and international travel required.
Essential Skills & Experience
- Bachelor’s degree or higher in Engineering, Biomedical Engineering, Quality Management, Life Sciences, or related discipline.
- Minimum 5 years’ experience in Quality Management within medical device manufacturing.
- Mandatory: Direct experience working with Class III medical devices.
- Proven experience with NMPA regulatory requirements and ISO 13485.
- Strong understanding of ISO 13485.
- Strong understanding of NMPA regulations for Class III medical devices.
- Excellent written and verbal communication skills in Mandarin and English.
- Strong leadership, analytical ability, and problem‑solving skills.
Desirable Skills & Experience
- Experience leading audits and working directly with NMPA authorities.
- Knowledge of ISO 14971 risk management.
- Knowledge of process validation (IQ/OQ/PQ).
- Knowledge of statistical process control and sampling plans (e.g., ISO 2859).
Vision RT is an Equal Opportunity / Affirmative Action employer, all qualified applicants will receive consideration for employment and development without regard to race, colour, religion, sexual orientation, gender, national origin, disability, or protected veteran status.
