QA - Customer Quality Engineer

【在醫療器材產業中，品質絕對是擺在第一位！】 我們的客訴團隊不是單純接電話接收客人的負面情緒，而是接收到客訴案件後展開調查、分析及實驗，並將整個過程產出報告回覆讓客人知道，若你想要了解到瑞健多樣產品的話這會是一個很好的機會 (若您想要了解的是一個產品的完整製造流程，可以參考QA - Quality Engineer (Product) )！ SHL Medical AG is a world-leading solution provider in the design, development and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland since late 2018. 【Job Overview】 The responsible area includes complaint handling process with customers, root cause investigation for product quality complaint, regulatory concern in critical quality event, post-market data analysis, and quality system activities. This position works closely with internal and external stakeholders to identify/ drive improvement initiatives in whole product lifecycle and quality management system so to ensure continuous product safety and effectiveness on the market. 負責與客戶的客訴處理流程、產品質量投訴的根本原因調查、重大質量事件中的法規考量、市場後數據分析以及品質系統活動。此職位需與內部及外部相關方密切合作，識別並推動整個產品生命周期和品質管理系統的改進措施，以確保產品在市場上的持續安全性和有效性。 【Main Responsibilities】 ‧ Serve as company liaison with foreign customers and deliver outstanding customer service to resolve product quality complaints ‧ Analyze complaint failure modes according to complaint descriptions, evaluation on returned defect samples, manufacturing records, and design history records ‧ Complete technical investigation and root cause analysis with cross functional team members ‧ Issue corrective and preventive action (CAPA) and verify the effectiveness of CAPA ‧ Compose and submit a detailed and high quality report for the root cause investigation ‧ Ability to effectively communicate and interact with foreign customers, team members, and various technical disciplines covering end-to-end product lifecycle (e.g. mechanical design, injection molding, plastics, metal, assembly, functional testing) ‧ Periodically complaint data analysis to identify actionable insights and continuous improvement for product/ process, and present complaint statistics to customers and management. ‧ Establish and maintain complaint investigation method and provide training to customer’s complaint handling center when required. ‧作為公司與外國客戶的聯絡人，提供卓越的客戶服務來解決產品客訴 ‧根據投訴描述、退回的缺陷樣品評估、製造記錄和設計歷史記錄分析投訴失效模式，與跨功能團隊成員完成技術調查和根本原因分析 ‧發佈糾正和預防措施（CAPA）並驗證其有效性 ‧撰寫並提交詳細且高質量的根本原因（RCA）調查報告 ‧能夠有效地與外國客戶、團隊成員和涵蓋端到端產品生命周期的各種技術領域進行溝通和互動（如機械設計、注塑成型、塑料、金屬、裝配、功能測試） ‧定期進行投訴數據分析，以識別可行的洞察和產品/流程的持續改進，並向客戶和管理層展示投訴統計數據 ‧建立和維護投訴調查方法，並在需要時為客戶的投訴處理中心提供培訓 【Required Skills & Qualifications】 ‧Bachelor or above degree in science or engineering background (e.g., mechanical, industrial engineering, biomedical, chemical engineering, material/life science) ‧Logical thinking and proficient problem-solving skills ‧Fluent English in speaking and writing with strong organizational and communication skills ‧Ability as a team player to frequently cooperate with cross-function team members in different ways (e.g., phone call/meeting/e-mail) ‧Time management ability to complete assigned jobs in a timely manner ‧Good flexibility/anti-stress ability to deal with different/urgent issues ‧理工科或工程學相關背景的學士或以上學位（如機械、工業工程、生物醫學、化學工程、材料/生命科學） ‧邏輯思維和熟練的問題解決能力 ‧流利的英語口語和寫作能力，並具有較強的組織和溝通能力 ‧作為團隊成員，能夠經常以不同方式（如電話會議、面談、電子郵件）與跨功能團隊成員合作 ‧時間管理能力，能夠及時完成分配的工作 ‧良好的靈活性和抗壓能力，能夠處理不同/緊急問題