1.Responsible to follow all applicable SOPs and WIs at all the times. 2.Responsible to follow the principle of GMP to the best of their ability at all times. 3. This job holder is capable of implementing job tasks below, -Author procedures, work instructions or other documents. -Review completeness of the Device History Records. -Issue Corrective and Preventive Actions (CAPA), leads cross functional team to perform root cause analysis and identify corrective actions. -Verify the effectiveness of corrective/preventive actions. -Assist QA Manager by participating in Non-Conforming Product, complaint, CAPA investigation. -Provide training to other function members in QA systems. -Participate in internal audits, and when require external audits. -Interfaces with other functions' members, customers and/ or suppliers to resolve issues. -Lead and draft Supplier Quality Agreement. -Evaluate and audit supplier (routine and ad hoc). -Review and approves supplier failure analysis relative to corrective action provided, and coordinate resolution of quality assurance related problems. -Identify, investigate, analyze and correcte problems in quality, production and control at a supplier locations, and escalate to QA Manager if any major systemic/production failures observed. -Drive supplier quality performance improvements. 4. Assign above job tasks by staffing qualification / personal ability / organization needs. 5. Carry out other duties as assigned. 1. 確實遵守所有適用的標準作業程序和工作指導書。 2. 確實遵循並落實優良製造規範。 3. 此工程師可協助完成以下工作需求, -編寫程序書、作業指導書或其他品質文件。 -審查醫材歷史記錄的完整性。 -發出矯正預防措施（CAPA），引導跨功能團隊來執行根本原因分析並確定矯正措施。 -驗證矯正預防措施的有效性。 -協助品質經理參加不合格產品、投訴之矯正預防調查。 -提供訓練予品質系統相關其他部門與同仁。 -參與內外部稽核活動。 -擔任與其他部門成員、客戶和/或供應商之間的溝通橋樑以解決品質問題。 -擬定供應商品質合約。 -供應商評估和供應商稽核。 -審核供應商稽核缺失回覆，協調品質相關的問題。 -辨識、調查、分析及協助矯正供應商品質上的問題，如有重大缺失，應及時回報品質經理。 -主導供應商品質改善計畫。 4. 依任用條件/個人能力/組織需求安排以上工作。 5. 其他主管交辦任務。

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.