-Comprehensive knowledge of quality systems. -Extensive knowledge of medical device regulation, industry or international standard, including risk management. -Ability to interpret the regulations/standards and Departments Procedures. -Participate in development of risk management documents. -Review results from activities related to Design Verification, Process Validation, Production and Post-production of Medical Devices -Understands team functions, leadership techniques and project management methodologies. -Broad knowledge of manufacturing processes. -Excellent communication skills in English (verbal, written, and presentation). Understands how to present information internally and externally. -Ability to effectively manage time. -Ability to handle multiple task assignments.

瑞健集團(SHL)成立於1989年，目標以西方管理模式在亞洲打造具有國際水準的生產中心。如今，在全球製藥及生物科技領域，SHL已成為藥物輸送系統的OEM/ODM領導製造商，如自動安全注射器。除此之外，SHL還擴展許多產品線，像是軟性結構類醫療產品、醫療氣墊床、醫療床、腦神經手術器具、工業 設備和醫療用吊昇設備等，目標市場為北美、歐洲及亞洲。 SHL (Scandinavian Health Ltd) is currently the world's largest privately-owned designer, developer and manufacturer of advanced drug delivery systems. The organization was established in 1989 by Swedish entrepreneurs Roger Samuelsson and Martin Jelf with the goal of combining world-class manufacturing in Asia with the strengths of Western Management practices. SHL manufactures devices including pen injectors, auto injectors and inhaler systems. We also manufacture a range of other products including pressure mattress systems, patient lifting slings, medical soft goods, beds, neurosurgical devices, catheters and industrial equipment.