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、文檔管理和驗證支持,支持新產品開發(fā)和系統(tǒng)改進計劃,加強項目交付能力。
核心職責
1. 新產品開發(fā)項目執(zhí)行支持
促進質量、法規(guī)、生產和英國團隊在新產品開發(fā)項目上的合作。
2. 文檔和法規(guī)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(xié)議(IQ/OQ/PQ)和其他相關文件等編寫。
o確保遵守法規(guī)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(yī)療器械)。
·語言能力:
英語:專業(yè)水平(書面/口語),能與英國團隊進行日常協(xié)調
·技術能力:
熟悉新產品開發(fā)文件(如FMEA,風險分析)。
能夠理解技術規(guī)范和法規(guī)要求。