Quality Engineer

- Lead the establishment and deployment of Product Quality systems in China, ensuring alignment with global QMS and regulatory requirements.  
负责在中国建立并部署产品质量体系，确保与全球质量管理体系及法规要求保持一 致

- Drive transfer of Product Quality processes, standards, and best practices to ensure consistent and compliant execution.  
推 动产品质量流程、标准及最佳实践的转移，确保执行一致性与合规 性

- Lead product quality management and continuous improvement through data analysis, root cause investigation, and CAPA/NCMR/complaint handling.

主 导产品质量管理与持续改进，包括数据分析、根因调查及 CAPA 、 NCMR 、投 诉处理 。

- Ensure QMS and regulatory compliance, including audit support and engineering change control (ECR/ECO).  
确保质量体系及法规合规，包括审核支持及工程变更管理（ ECR/ECO ）

- Ensure China site compliance with ISO9001, ISO13485, and FDA 21 CFR Part 820 requirements, and support and lead internal and external audits, including preparation, execution, and   timely   closure of audit findings.  
确保中国工厂符合 ISO9001 、 ISO13485 及 FDA 21 CFR Part 820 法 规要求，并支持和主导内外部审核，包括审核准备、执行及问题的及时关闭

- Any agreed-to works by superiors.

上级安排其它的工作

The   essential requirements of the job i nclude

- Bachelor’s degree in Engineering   or equivalent.

工程 类本科或同等学 历 。

- 3-5   years experience   in product or manufacturing quality.

3-5   年 产品或制造质量经验 。

- Experience in process transfer, NPI or site setup preferred.

具有流程 转移、新产品导入或工厂建设经验者优先 。

- Excellent verbal and written communication skills, including   ability   to effectively communicate with internal and external customers.

具备优秀的口头和书面沟通能力，能够与内部及外部客户进行有效沟通 。

- Organized and detail-oriented with   a high level   of initiative, self- motivation   and energy

做事有条理、注重细节，并具备高度主动性、自我驱动力和充沛精力 。

Travel, Motor Vehicle Record & Physical/Environment Requirements:   出差、机 动车驾驶记录及身体 / 环境要求 ：

- Ability to travel – 5 % travel, overnight, within territory or   occasional international travel

可接受出差 —— 约 5% 的出差 频率，需过夜，在所负责区域内出差或偶尔进行国际出 差

It would be a plus if you also   possess   previous   experience in:   如果您 还具备以下经验将更具优势 ：

- Strong knowledge of ISO9001, ISO13485, FDA QSR , China NMPA

熟悉 ISO9001 、 ISO13485 ,   FDA   及   中国法 规 等 。

- Familiar with quality tools such as FMEA, SPC, DOE , MSA .

熟悉 FMEA 、 SPC 、 DOE 、 MSA 等 质量工具 。

- Strong cross-site communication and stakeholder management skills.

具 备良好的跨工厂沟通及协作能力 。

- Willing to travel between Singapore and China.

可接受新加坡与中国之 间的出差要求 。

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com .