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。