Quality Assurance Manager

12 hours ago


hong kong, Hong Kong SAR China ARAL Holdings Limited Full time

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. Interested parties, please send the CV to "APPLY NOW"/ ***Personal data collected will be used for recruitment purposes only*** #J-18808-Ljbffr



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