QA - RCA 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】

• Develop and deliver training programs on RCA methodologies, tools, and best practices.
• Conduct workshops, seminars, and hands-on training sessions to enhance the RCA skills of investigation Plan owners.
• Provide coaching and mentorship to individuals or teams to improve their RCA capabilities.
• Monitor the performance of RCA investigations across various projects or departments.
• Analyze investigation outcomes and identify areas for improvement.
• Implement KPIs to measure the effectiveness and efficiency of RCA processes.
• Continuously evaluate and refine RCA processes and methodologies to ensure effectiveness and efficiency.
• Collaborate with cross-functional teams to implement process improvements and standardize RCA practices across the organization.
• Stay updated on industry trends, emerging technologies, and best practices related to RCA.
• Foster a culture of collaboration and knowledge sharing among team members involved in RCA.
• Collaborate with various departments to gather relevant data and insights for RCA investigations.
• Communicate findings, recommendations, and action plans to stakeholders iin a clear and concise manner.
• 制定並提供有關 RCA 方法、工具和最佳實踐的培訓計劃。
• 舉辦工作坊、研討會和實踐培訓課程，以提高調查計畫負責人的 RCA 技能。
• 為個人或團隊提供輔導和指導，以提高他們的 RCA 能力。
• 監控各個專案或部門的 RCA 調查績效。
• 分析調查結果並確定需要改進的領域。
• 實施KPI 來衡量 RCA 流程的有效性和效率。
• 持續評估和完善 RCA 流程和方法，以確保有效性和效率。
• 與跨職能團隊合作，實施流程改善並標準化整個組織的 RCA 實踐。
• 隨時了解與 RCA 相關的行業趨勢、新興技術和最佳實踐。
• 在參與 RCA 的團隊成員之間培養協作和知識共享的文化。
• 與各部門合作，收集 RCA 調查的相關數據和見解。
• 以清晰簡潔的方式向利害關係人傳達調查結果、建議和行動計劃。

【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。