• New Product IntroductionNew product evaluation and generate QVP, TF collection and review, monitor product verification during product developing stage, product certification testing manage, drive product validation to compliance EC regulation of MDD & IVD, Checklist preparation, production line visit and manufacturing processes evaluate, and uses engineering skills to improve and follow up with supplier• Product monitorUses engineering skills to analysis and support supplier for the NC manage, ECN manage and reverification and revalidation, uses engineering skills to coordinate the cross function teams to manage the shipment release.Setup products certification testing renew and monitor, buildup new/update regulation compliance plan and follow up. • Supply Chain ManagementPotential supplier assessment audit of according to ISO 13485 and follow up, setup the audit plan and checklist and rating system for the qualify supplier, Setup the system to monitor supplier quality performance and enhance supplier quality and continue improvement.Good experience in products & solutions of Thermometer(IR, Digital), Nebulizer (ultrasonic, pressure & mesh), Venipuncture(lancet, scalp vein set, and syringe), humidifier, BPM and etc