1. Participate in design review meetings to review all quality aspects of new products. Work with Design & Product Development Engineers to ensure quality considerations during the concept stage. 2. Assess the risk mitigation techniques implemented and whether these are consistent with the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls – UFMEA, DFMEA, PFMEA. 3. Review and coordinate with Validation for all test method and design validations. 4. Supports product lifecycle through; - Data collection and analysis - Continuous process improvement & review the level of control in manufacturing processes including the adequacy of current process limits. - Reduction of reject levels - Ensure there are adequate product and process controls in place for identified critical or major quality attributes/process parameters - Investigate and/or provide input on non-conformance events and Corrective Actions and Preventive Actions (CAPA). - Provide support for quality measurement and inspection systems and quality indicating measurement methods and standards. - Use statistical and problem-solving tools as part of delivering improvement opportunities. Additional Responsibilities May Include: - Material Review Board - Change Request & review board - Support scientific, complaint, and test failure investigations - Participate in Quality Plan development. - Directs the efforts of others such as technicians and outside resources.

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.