- Handle CAPAs and participate in internal /external audits- Develop, perform, and maintain internal validations and validation documentation- Develop and maintain internal QMS documents and processes

I oversee the operation and support functions for a mid-sized medical diagnostic laboratory, including:- Executed and streamlined the laboratory operation and developed SOP (material QC, equipment maintenance, inventory management, reagents and consumables procurement)- Took part in regular quality inspection, risk assessment and ISO 15189/27001/13485 internal and external audit- Built a robust international supply chain (procurement and logistics)- Supported the establishment of the pathology lab for cancer diagnosis service (including staining and imaging equipment procurement)- Communicated with Danish/Chinese/others vendors and property management; internal sectors in Hong Kong and Shenzhen