负责西门子实验系统（上海）有限公司（以下简称“上海工厂”）全面验证活动，并作为主题研究专家，主导或评估各项验证活动，确保上海工厂的各项验证活动能满足法规和公司内部的要求。 Responsible for overall validation system activities in Siemens Healthineers Laboratories (Shanghai) Co., Ltd (hereinafter referred to as Shanghai plant), acting as SME to lead or evaluate each validation activity, ensure Shanghai plant validation can meet regulatory and company requirements.

工作内容：

- 负责确保上海工厂验证管理体系满足国内药监局和西门子医疗质量管理体系的要求，不断持续监控与改善。

- Responsible for ensuring Shanghai plant meet NMPA and Siemens Global validation requirement, continuously monitoring and optimization.

- 主导/审核各项验证活动；作为上海工厂的验证主题专家，协调内外部的沟通和推动事务进行。

- Lead/review each validation activity: Act as Shanghai plant validation SME, coordination internal and external parties and facility events going forward.

- 负责参与西门子医疗总部或上海工厂的质量项目活动，推进项目在上海工厂的落实。

- Responsible for participating in Siemens Global or Shanghai plant quality projects to ensure implementation.

- 负责完成上级或公司指派的其他相关项目或任务。

- Responsible for completing other related projects or tasks assigned by management or the company.

经验：

- 从事医疗器械质量保证工作至少 8年，其中至少 5年以上为验证相关的工作经验

Minimum of 8 years in medical device quality with at least 5 years of validation experience.

-精通验证方法（IQ/OQ/PQ，PPQ）及工具；具有厂房/设备、产品工艺等多项验证主导或参与经验。

Strong knowledge on validation method (IQ/OQ/PQ, PPQ) and applicable tools; rich experience on facility/equipment, product process validation lead or participation experience.

-具有风险管理管理与统计技术的候选者优先考虑。

-能够分清多任务项目的轻重缓急，在压力下可以良好工作。

Ability to prioritize and juggle multiple projects and thrive under pressure.

-具备良好的英语口语和书面表达能力。

Good oral and written English is required.