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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(xié)調(diào)、文檔管理和驗(yàn)證支持，支持新產(chǎn)品開發(fā)和系統(tǒng)改進(jìn)計(jì)劃，加強(qiáng)項(xiàng)目交付能力。 核心職責(zé) 1. 新產(chǎn)品開發(fā)項(xiàng)目執(zhí)行支持 促進(jìn)質(zhì)量、法規(guī)、生產(chǎn)和英國團(tuán)隊(duì)在新產(chǎn)品開發(fā)項(xiàng)目上的合作。 2. 文檔和法規(guī)遵從性 管理供應(yīng)商溝通，為產(chǎn)品驗(yàn)證編寫技術(shù)文檔。 支持驗(yàn)證協(xié)議（IQ/OQ/PQ）和其他相關(guān)文件等編寫。 o確保遵守法規(guī)標(biāo)準(zhǔn)（ISO 13485）和內(nèi)部質(zhì)量體系。 資格 ·經(jīng)驗(yàn): 2-4年工程/項(xiàng)目工作經(jīng)驗(yàn)（醫(yī)療器械）。 ·語言能力： 英語：專業(yè)水平（書面/口語），能與英國團(tuán)隊(duì)進(jìn)行日常協(xié)調(diào) ·技術(shù)能力： 熟悉新產(chǎn)品開發(fā)文件（如FMEA，風(fēng)險(xiǎn)分析）。 能夠理解技術(shù)規(guī)范和法規(guī)要求。