Sterility Assurance Engineer
Johnson & Johnson Family of CompaniesSuzhou(Anhui)Update time: May 21,2019
Job Description
- Understand and maintain in collaboration with manufacturing all the processes related to a given group of products.和生产合作，理解和维护给定产品族相关的所有工艺。
- In connection with other departments in China and Overseas, to guarantee in-time and compliant manufacturing start-up in China in order to support all business objectives.联系中国和海外的其它部门，确保中国启动生产的及时性和合规性，支持业务目标。
- In partnership with microbiologist:和微生物人员合作
- Develop, implement, maintain and continuously improve the microbial assurance (microbiology and sterilization) aspects of the Quality System.开发、执行、维护和持续改善质量体系的微生物保障方面（微生物和灭菌）。
- Conduct cleaning/sterilization validations of terminally sterilized medical devices using Gamma irradiations or other sterilization methods.执行终端灭菌医疗器械（gamma辐照灭菌或者其他灭菌方式）的清洗/灭菌验证工作。
- Validate the microbial aspect of related equipments and processes.相关设备和工艺的微生物方面验证工作。
- Develop and implement all procedures for microbial assurance activities in accordance with all applicable requirements.开发和执行微生物保障活动的所有程序，符合所有适用的要求。
- Carry out regular monitoring of all microbial systems (i.e. water systems, cleanliness, washers, cleanrooms…).执行所有微生物体系的常规监控（如水系统、清洁、清洗机和洁净室）。
- Provide support to GMP training programme for clean room and other appropriate staff.提供洁净室和其他相关员工GMP培训项目的相关支持。
- Carry out regular internal auditing of all clean rooms and other areas.完成所有洁净室和其他区域的常规内审。
- Perform external audits of sterilization subcontractors, contract laboratories and clean room clothing suppliers.执行灭菌承包商、合同实验室和洁净服供应商的外部审计。
- Support R&D on new products development.支持R&D新产品开发。
- In accordance with JJMSZ Quality strategy, participate to the development of the quality system and its day to day implementation:根据JJMSZ全球质量策略，参与质量体系开发和日常执行。
- Participate in training for workshop employees and deploy on site the Quality philosophy based on FDA QSRs, ISO 13485 and SFDA requirements.参与车间员工培训，基于FDA QSRs, ISO 13485和SFDA要求，现场部署质量理念。
- Ensures compliance to all GMPs and MDD requirements.确保符合所有GMPs和MDD要求。
- Conduct internal and supplier quality audits at a Lead Auditor level as required.按要求，在主审层级上，执行内部和供应商质量审计。
- Use PE principles to propose, develop and implement programs to improve quality, scrap rates, lead times, or any other program defined by the management. 应用PE原则建议、开发和执行项目，提高质量、改善报废率、交货时间或者管理层定义的任何其它项目。
- Perform all job duties in full accordance with:所有工作职责完全符合：
- The J&J policies on Information, Assets protection, Maintain password(s) confidential, protect critical Business Information. J&J信息政策、资产保护、密码保密维护、关键业务信息保护。
- All J&J policies and local regulations.所有J&J和当地法规要求。
- The policies of the Health Care and Environmental programs.医疗健康政策和环境项目。
- The code of conduct policies.行为准则。
- Full responsibility and ownership (like all employees on site) for all audits (internal, Corporate, External, for Quality, H&S, Environment, etc…).对所有审计（内审、合作、外审、对质量、H&S、环境等），负全责和所有权（比如所有员工在现场）
Qualifications
- Strong technical skills 良好的技术能力
- Strong work ethic良好的工作精神
- Influencing Skills影响力
- Negotiating Skills沟通能力
- Effective Communicator有效的沟通者
- Planning & Organizing Skills计划&组织能力
- Judgment判断力
- Fair & Reasonable Approach公正&合理
- Confidentiality自信力
- Customer and Quality focus聚焦客户和质量
- Strong ability to work in a cross functional structure良好跨部门合作的工作能力
- Degree in Chemical/Micro. Analysis or equivalent化学/微生物分析或者等同的学位
- Statistics and Process capability统计和处理能力
- Project Management项目管理能力
- English at a business level商务水平英语
Primary Location
China-Anhui-Suzhou-No. 299, Changyang Street, Suzhou Industrial Park
Organization
Johnson & Johnson Medical Suzhou Ltd. (7054)
Job Function
Quality Assurance
Requisition ID
1905733885W
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