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.


通过跨职能协调、文档管理和验证支持，支持新产品开发和系统改进计划，加强项目交付能力。
核心职责
1. 新产品开发项目执行支持
促进质量、法规、生产和英国团队在新产品开发项目上的合作。
2. 文档和法规遵从性
管理供应商沟通，为产品验证编写技术文档。
支持验证协议（IQ/OQ/PQ）和其他相关文件等编写。
o确保遵守法规标准（ISO 13485）和内部质量体系。
资格
·经验:
2-4年工程/项目工作经验（医疗器械）。
·语言能力：
英语：专业水平（书面/口语），能与英国团队进行日常协调
·技术能力：
熟悉新产品开发文件（如FMEA，风险分析）。
能够理解技术规范和法规要求。