Quality Operations Manager

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:
People Leader

All Job Posting Locations:
Suzhou, Jiangsu, China

Job Description:

Business Improvements 业务改进


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

主导或支持质量改进活动，对产品/制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

工具和程序。


* Conduct benchmarking with external companies or internal sites to develop more effective methods for improving quality.

通过与外部公司或内部研究中心标杆管理开发更有效的质量管理方法提升质量。


* Establish metrics that are leading and lagging indicators of quality.

建立质量相关的领先和滞后指标的度量标准。


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

       支持质量工程、质量合规、质量领导人才的发展，为新产品的导入和产品生命周期管理提供正

确的技能。


* Establish Quality cost categories and Quality cost bases.

建立质量成本类别和质量成本的基础。

Compliance/Regulatory合规/法规


* 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过程是否合规，比如QSRs，ISO13485等法规要求


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

China GMP, QSRs, ISO, EN and MDR 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(例如中国GMP, QSRs, ISO, EN和MDR要求)。


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

       执行周期审核以评估生产控制的适当性，例如批次隔离。评审区域审核...