Reports to: General Manager Supervises: LK Quality Manager (dotted) Develop/Implement/Maintain quality control and quality assurance programs that are in full compliance with various regulatory and CGMP requirements from FDA, CFDA, ANVISA, CE and many other regulatory bodies of the countries where company’s products are exported. Serve and function as Quality System Management Representative (QSMR) of the factory. Support all aspects of company’s factory relocation planning & execution of the plan including, but not limited to new factory registration and certification, factory qualification and master validation plan, Process & Equipment validation, writing relevant validation proposals and reporting to Sr. management, and etc. Analyse, evaluate and present information to Sr. management, concerning annual management reviews, regulatory requirement changes, certification & licensing requirements and renewals, customer complaints, customer quality audits, internal quality audits, and CAPA plan. Work together with factory GM to develop annual Quality Departmental objectives/goals. Lead the LK quality team in customer complaint investigations which may be relating to possible medical device reporting as required by Regulatory bodies. Lead company’s Quality initiatives to establish and review internal quality programs to improve product quality and regulatory compliance at the factory. Lead internal quality audit programs and report to the company’s Management. Ensure that all local sites are trained and are in compliance with company’s Quality System requirements. Lead/Participate in CAPA and Risk Analysis meetings for regulatory and customer complaint cases. Manage/host quality audits from customers and external regulatory bodies. Support to implement factory quality performance metrics, such as KPIs, and provide monthly Quality Reports to Sr. management. Provide Quality personnel in the factory with good coaching, training and effective development plan. Support/Participate factory Lean Improvement projects. Support CSR Manager and help CSR CAPA activities. All other duties as assigned.
BS in science, engineering or medical technology. 10+ years’ experience in quality control/assurance in any industry Minimum 5+ years of quality experience in medical device industry in lieu of 10+ years requirement. 2+ years’ experience in quality management position Proven leadership & problem solving skills. Highly motivated, detail and team oriented Strong interpersonal and communication skills. Proficiency in written and spoken English, Cantonese and Mandarin Ability to work alone and minimal supervision required. Willingness to travel and to spend 3 days per week in PRC. Ability to travel, internationally