1. 協(xié)助開展新產(chǎn)品開發(fā)與系統(tǒng)改進項目，協(xié)調(diào)質(zhì)量、法規(guī)、生產(chǎn)及海外團隊，保障項目執(zhí)行與交付；負責部分新產(chǎn)品供應商溝通對接，參與編寫驗證協(xié)議（IQ/OQ/PQ）及技術文檔，確保符合 ISO 13485 等法規(guī)標準及內(nèi)部質(zhì)量體系要求。
Coordinate new product development and system improvement projects, conduct cross-functional coordination with quality, regulatory, production and overseas teams to support project execution and delivery, manage communication with new product suppliers, participate in the writing of verification protocols (IQ/OQ/PQ) and technical documents, and ensure compliance with regulatory standards such as ISO 13485 and internal quality system requirements.
2. 深入?yún)⑴c研發(fā)與新產(chǎn)品開發(fā)流程，協(xié)助編寫及整理體系要求的設計相關文件（如設計輸入、設計輸出、評價等），確保滿足體系規(guī)范。
Deeply involved in the R&D and new product development processes, providing material, process and technical advice from the conception stage, promoting the application of innovative and sustainable materials, collaborating with the procurement department to optimize the supplier network, reducing supply chain risks and costs, and supporting supplier relationship management and contract negotiations.
3. 負責日常郵件處理、會議組織及臨時事項的跟進與改進工作，推動現(xiàn)有產(chǎn)品、生產(chǎn)工藝與材料的質(zhì)量提升。
Responsible for handling daily emails, meetings and following up on temporary matters for improvement, promoting the quality enhancement of existing products, processes and materials, introducing alternative materials and processes to improve quality and profits, and leading related projects such as increasing the proportion of internal manufacturing.
4. 協(xié)助開展公司內(nèi)外部審核工作，積極跟進不符合項的整改與閉環(huán)處理，確保研發(fā)部門體系持續(xù)合規(guī)；有效響應監(jiān)管機構要求，及時編制、更新并維護研發(fā)產(chǎn)品相關法規(guī)文件。
Assist the internal and external audit work of the company, actively follow up on the improvement and closed-loop handling of non-conformities, ensure the continuous compliance of the quality management system, and effectively respond to the requirements of regulatory authorities. Timely prepare, update and maintain relevant regulatory documents.
5. 協(xié)助推進產(chǎn)品與過程的變更申請、等同性報告、風險評估等體系文件的編制與完善工作，確保醫(yī)療器械的安全性、有效性及合規(guī)性。
Be responsible for the daily operation and maintenance of the quality management system, take the lead in conducting risk assessments of products and processes, ensure the safety, effectiveness and compliance of medical devices, and promote the implementation of relevant follow-up measures.
6. 隨著公司持續(xù)發(fā)展與進步，個人接受公司對本研發(fā)崗位職責的必要調(diào)整與優(yōu)化，并積極配合執(zhí)行。
As the company continues to develop and progress, person should accept any necessary adjustments and optimizations of the job responsibilities made by the company at any time and actively cooperate.

崗位需求：
1、具體相關經(jīng)驗
2、熟練的工作英文語言交流
3、責任心強，優(yōu)秀的職業(yè)道德和職業(yè)操守
4、福利待遇優(yōu)，彈性工作制