Quality Engineer

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Quality

Job Sub Function:
Quality Assurance

Job Category:
Professional

All Job Posting Locations:
Suzhou, Jiangsu, China

Job Description:


* Business Improvements 业务改进


* Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.


* 支持质量改进活动，对产品/过程进行持续改进和成本改善。


* Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.


* 评估和分析质量工具及项目的有效性，比如PDCA，六西格玛，改善，精益技术和/或其他改进工具。


* Conduct benchmarking to develop more effective methods for improving quality.


* 通过标杆管理开发更有效的质量管理方法提升质量。


* Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management.


* 开发合适的质量管理方法应用于质量工程和质量合规的发展，运用在新产品导入和产品生命周期管理。


* Compliance/Regulatory 合规管理


* Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc.


* 评估和分析现有产品和制程是否合规，比如QSRs，ISO13485等法规要求


* Champions compliance to applicable Global Regulations and standards (e.g.

QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.


* 支持工厂的内外部审核，遵守适用的法规和标准(例如QSRs, ISO, EN和MDD)要求。


* Conduct periodic line audits to assess for production controls such as lot segregation.  Review results of area audits to ensure that corrective and preventive actions are adequate.


* 执行周期审核评估生产现场是否合规。审阅区域审核的结果确保纠正和预防措施有效。


* New Product/Process Introduction 新产品/制程导入


* Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.


* 协调研发和其他的跨部门合作确保相关领域质量管理可控。比如设计管理ï...