Purpose Statement: This position is to provide quality oversight to assure design, development, manufacturing, and post-market of SHL product are compliant to applicable regulations, standards, and SOPs. QA engineer ensures the delivery of high quality product which meet the regulatory requirements and customer expectations. Key Responsibilities: 1. Lead / participate in project related quality activities (e.g. design control, change control, product release) and provide quality consultation to the team. 2. Demonstrate customer focus, cross-functional cooperation skills, and sound quality judgement. 3. Complete the evaluation and detailed investigation on the observed nonconformities during manufacturing process. 4. Present accumulated quality data to customers and management. 5. Identify trends of quality data with the usage of statistics and quality improvement tools to prevent quality issues. 6. Ability to effectively communicate and interact with foreign customer, team members, and various technical disciplines. 7. Support external quality inspections and execute internal and supplier audits. 8. Complete assigned tasks on time with minimal supervision (self-motivated).

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.