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 recognized 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 2026 King’s Award for Enterprise, our fifth in 10 years. It is the UK’s most prestigious accolade for business excellence.
Company video
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 organization in which to work.
About the role
The Quality Manager is responsible for leading quality management and regulatory support for a Class III medical device manufacturing operation in Beijing, with headquarters in the UK. This role ensures the organisation in China maintains compliance with applicable regulatory requirements—including China NMPA regulations and ISO 13485. The Quality Manager champions continuous improvement of Vision RT's quality management system and smooth introduction of new product lines and processes. They train internal staff on their compliance responsibilities and liaise with the NMPA and other external stakeholders to demonstrate Vision RT's commitment to quality
Key responsibilities will include
• Lead quality assurance and quality control activities for manufacture of Class III medical devices at Vision RT’s factory in Beijing, China.
o Act as management representative and head of quality management within the QMS.
o Maintain and continually improve the ISO 13485‑compliant QMS and ensure alignment with NMPA medical device regulations for Class III products.
o Lead and maintain PFMEA and process validation activities for new and existing manufacturing processes.
o Ensure that tools are maintained and calibrated according to manufacturer’s instructions and maintenance schedules.
o Review and implement engineering, design, and documentation changes impacting production.
o Oversee in‑process and final product quality control.
o Lead internal and external audits (NMPA inspections, supplier audits, internal audits).
o Ensure effective CAPA, non-conforming product, complaint handling, and process risk management processes.
o Deliver QMS and regulatory compliance training for China-based staff.
• Support interactions between Vision RT and the NMPA, including with consulting agencies on facility inspections and licensing.
• This role requires national and international travel.
Essential Skills & Experience
Experience
• Minimum 5 years of experience in quality management within medical device manufacturing.
• Experience with Class III medical devices.
• Strong background in NMPA regulatory requirements.
• Experience leading audits and interacting with the NMPA.
Technical Skills
• Strong understanding of:
o NMPA regulations for Class III devices
o Process validation (IQ/OQ/PQ)
o Statistical process control and sampling plans (e.g., ISO 2859)
• Confident in general computer usage, including the Microsoft Office package.
Soft Skills
• Excellent written and verbal communication skills in Mandarin (fluent) and English (at least C1 level).
• Strong leadership, analytical thinking, and problem‑solving abilities.
• Ability to collaborate cross‑functionally in a global environment.
Residence
• Must be a resident of Beijing.
Desirable Skills & Experience
Education
• Bachelor’s degree or higher in Engineering, Biomedical Engineering, Quality Management, Life Sciences, or a related field.
Experience
• Application of ISO 13485.
Technical Skills
• Understanding of:
o ISO 13485
o ISO 14971 process risk management
Skills Required
- Minimum 5 years' experience in Quality Management within medical device manufacturing
- Experience working with Class III medical devices
- Strong knowledge of NMPA regulatory requirements and experience liaising with NMPA
- Experience leading audits (internal, supplier) and supporting NMPA inspections
- Experience leading PFMEA and process validation (IQ/OQ/PQ)
- Knowledge and application of Statistical Process Control (SPC)
- Experience with sampling plans (e.g., ISO 2859)
- Proficient in Microsoft Office applications
- Fluent Mandarin and English (minimum C1 level)
- Resident of Beijing
- Strong leadership and stakeholder management skills
- Experience managing CAPA, non-conforming product processes, complaints and risk management
- Bachelor's degree or above in Engineering, Biomedical Engineering, Quality Management, Life Sciences or related discipline
- Practical experience applying ISO 13485 within a manufacturing environment
- Understanding of ISO 14971 risk management principles
What We Do
Vision RT is the inventor of Surface Guided Radiation Therapy (SGRT), specializing in the design and development of innovative optical surface imaging technologies for radiation therapy. Founded in 2001, the company produces solutions that improve the accuracy, efficiency, safety, and comfort of radiotherapy workflows—spanning simulation, planning, treatment, and dose visualization—with the ultimate goal of enhancing patient care and outcomes in the treatment of cancer.
