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To strengthen project delivery capabilities by supporting New Product Development and system improvement initiatives through cross-functional coordination, documentation management, and validation support. Core Responsibilities 1.Project Execution Support o Facilitate collaboration between Quality, Regulatory, Production, and UK teams on projects. 2. Documentation & Compliance o Manage vendor communications to compile technical documentation for product validations. o Support validation protocols (IQ/OQ/PQ) and other related documents writing. o Ensure adherence to regulatory standards (ISO 13485) and internal quality systems. Qualifications · Experience: o 2–4 years in engineering/project roles (medical devices). o Exposure to cross-functional project delivery. · Language Skills: o English: Professional proficiency (written/spoken) for daily coordination with UK team · Technical Competencies: o Familiarity with NPD documents (e.g., FMEA, risk analysis). o Ability to interpret technical specifications and regulatory requirements. 通過跨職能協調、文檔管理和驗證支持，支持新產品開發和系統改進計劃，加強項目交付能力。 核心職責 1. 新產品開發項目執行支持 促進質量、法規、生產和英國團隊在新產品開發項目上的合作。 2. 文檔和法規遵從性 管理供應商溝通，為產品驗證編寫技術文檔。 支持驗證協議（IQ/OQ/PQ）和其他相關文件等編寫。 o確保遵守法規標準（ISO 13485）和內部質量體系。 資格 ·經驗: 2-4年工程/項目工作經驗（醫療器械）。 ·語言能力： 英語：專業水平（書面/口語），能與英國團隊進行日常協調 ·技術能力： 熟悉新產品開發文件（如FMEA，風險分析）。 能夠理解技術規范和法規要求。