QA - Engineer

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.

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。

【Job Overview】

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. 這個職位的目的是進行品質把關，確保 SHL 產品的設計、開發、製造和上市後階段皆符合相關法規、標準和標準作業程序 (SOPs)。品質保證工程師需確保產品的高品質交付，並滿足法規要求和客戶期望。

【Responsibilities】

• Lead / participate in project related quality activities (e.g. design control, change control, product release) and provide quality consultation to the team.
• Demonstrate customer focus, cross-functional cooperation skills, and sound quality judgement.
• Complete the evaluation and detailed investigation on the observed nonconformities during manufacturing process.
• Present accumulated quality data to customers and management.
• Identify trends of quality data with the usage of statistics and quality improvement tools to prevent quality issues.
• Ability to effectively communicate and interact with foreign customer, team members, and various technical disciplines.
• Support external quality inspections and execute internal and supplier audits.
• Complete assigned tasks on time with minimal supervision (self-motivated).
• 領導/參與與專案相關的品質活動，並向團隊提供品質建議。
• 必須展現以客戶為導向的態度，跨部門合作技巧以及良好的品質判斷能力。
• 在製造過程中對觀察到的不符合項目進行評估和詳細調查。
• 向客戶和管理層呈現累積的品質數據。
• 利用統計和品質改進工具識別品質數據的趨勢，以預防品質問題再犯。
• 能有效地與外國客戶（歐美及日韓地區居多）、團隊成員和各種技術專業互動和溝通。
• 支援外部品質檢查並執行內部和供應商審核。
• 能在時間內主動積極的完成被分配的任務

【Qualification】

• BS degree above or equivalent technical work experience.
• Clear / logical thinking with strong organization and communication skills
• Proficient problem solving skills.
• Working knowledge of Microsoft Office.
• Experience in the medical device industry is preferred.
• Knowledge of regulatory compliance: GMP (good manufacturing practice), QSR (quality system regulations), and ISO 13485 is preferred.
• CQT (certified quality technician), CQE (certified quality engineer) is a plus.
• Six sigma green belt or black belt is a plus.
• 工程學士學位以上或品質/製成相關工作經驗。
• 具有清晰/邏輯思維和良好的組織和溝通能力。
• 熟練的解決問題能力。
• 熟悉Microsoft Office軟體。
• 具有醫療器械行業經驗者優先考慮。
• 熟悉法規合規要求：GMP、QSR、和ISO 13485者優先考慮。
• 持有CQT（認證品質技術員）、CQE（認證品質工程師）證書者優先加分。
• 擁有六標準差綠帶或黑帶證書者優先加分。