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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(guò)跨職能協(xié)調(diào)、文檔管理和驗(yàn)證支持，支持新產(chǎn)品開(kāi)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(kāi)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(guó)團(tuán)隊(duì)在新產(chǎn)品開(kāi)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(xiě)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(xiě)。
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(yǔ)言能力：
英語(yǔ)：專(zhuān)業(yè)水平（書(shū)面/口語(yǔ)），能與英國(guó)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(kāi)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。