| 工作內容 |
1. 遵守所有適用的 SOP、WI 和 GxP (GMP, GDP, GLP) 原則。
2. 在指導與協助下執行測試任務，包括工程測試、可行性研究、設計評估和設計驗證。
3. 於實驗室資源故障時提供及時的解決及排除方案和支援。
4. 識別產品問題的趨勢/模式，並有效地與管理層溝通需要改進的地方。
5. 確保工程師可以獲得足夠的實驗室資源，包括設備、材料、操作技能培訓等。
6. 遵循實驗室安全、設備驗證、校準和維護計劃，並協助上述計畫的執行和狀態檢查。
7. 確保與協助實驗室的運行、權限和環境控制持續滿足品質管理系統的要求。
8. 在指導和協助下進行包含測量數據、設計驗證的結果分析，向專案團隊提供產品性能與品質改善的建議。
9. 在指導和協助下，評估標準、法規和指引(例如 FDA, EMA)對設計驗證/產品認證、可靠性和品質活動的適用性，並按要求進行上述測試活動。
10. 在指導與協助下撰寫設備操作手冊/測試指導書以及工程分析文件。
11. 上述工作任務外，根據個人能力和組織需求執行其他指派的任務。
1. Follow all applicable SOPs, WIs and principles of GxP (GMP, GDP, GLP) to the best of their ability at all times.
2. Execute tests, including engineering tests, feasibility studies, design assessment and design verification, with supervision and instruction.
3. Provide immediate solutions and troubleshooting support for issues or malfunctions in laboratory resources.
4. Recognize trends or models in product issues then effectively inform and have further discussion with management of those that require improvement.
5. Ensure laboratory resources, including equipment, materials, operation skill training, etc. are available to engineers.
6. Adhere to laboratory safety rules, equipment qualification, calibration, and maintenance plans, while assisting in routine activities above and status checks.
7. Ensure that laboratory operations, access, and environmental controls comply with the requirements of the quality management system.
8. Perform data analysis, with guidance and supervision, including measurement data and design verification results, and provide suggestions for product performance and quality improvement to the project team, based on the analysis results.
9. Evaluate the applicability of standards, regulations and guidelines (e.g., FDA, EMA) for design verification/product certification, reliability and quality activities and perform the above test activities as required, with guidance and supervision.
10. Establish equipment operation/test instruction and engineering/analysis documents, with guidance and supervision.
11. Perform additional tasks as assigned that are based on personal abilities and organizational needs, in addition to the responsibilities listed above.
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