Our client is a pioneering robotics company revolutionizing surgical technology through intelligent, next-generation solutions. As they expand across Hong Kong and China, theyre seeking a seasoned Quality Assurance Manager to lead regulatory compliance and elevate product excellence in the medical device space.
Key Responsibilities
- Ensure full compliance with ISO 13485, CE Mark, FDA 510(k), NMPA, and other regulatory standards.
- Lead quality systems across Hong Kong and China sites, including audits, certifications, and training.
- Oversee supplier quality and ensure adherence to safety protocols.
- Manage internal and external audits, regulatory reporting, and complaint investigations.
- Drive software validation planning and quality documentation.
- Report regularly to executive leadership on quality performance and system effectiveness.
Ideal Profile
- Degree in science, engineering, or medical technology.
- 8+ years of experience, with 3+ years in QA management within medical devices.
- Strong leadership and stakeholder communication skills.
- Fluent in English, Cantonese, and Mandarin.
- Familiar with ISO 13485, FDA 510(k), CE Mark, NMPA.
- Willing to travel across China and internationally.
- IP experience is a plus.
- Immediate availability or short notice is highly preferred.