岗位概述：
? 执行与质量控制和质量保证有关的各项技术职责，诸如建立检测的程序和方法，跟内外部技术专家的沟通，以及方法验证的完成
? 执行外科手术产品生产过程中的质量控制和质量保证。
? 工作范围涵盖爱惜康苏州工厂的超声刀产品。
? Perform various technical duties of quality control and quality assurance such as: Establish inspection procedures and methods, communicate with internal and external SMEs and finish test method validation
? Perform quality control and quality assurance during surgical product manufacturing.
? Work scope cover ultrasonic knife product in Ethicon Suzhou site.
岗位职责：
o 关注所有与成品质量保证有关的所有职能。
o 建立与维护应质量保证活动和质量文件体系所要求的适当文件。
o 开发统计取样方案以及进行过程能力的研究。
o 实施过程控制系统和提供为过程确认提供技术支持。
o 完成新测试方法的方法验证方案和报告。
o 在产品转移和新产品开发时提供质量体系的支持。
o 协助新工程师的培训，在过程发生变更时，培训技术人员和主管。
o 需要时进行投诉分析和调查。
o 参与过程和质量改进项目。
o 支持公司目标的发起活动。
o 负责执行安全管理工作。
o 安全政策和程序的符合合规要求。
o 遵守强生和Ethicon适用的有关信息、记录保存计划、培训与教育、文档保存通知、记录清理、失效记录和信息管理、关键记录以及第三方的记录管理要求。
o 协助、审阅和批准不合格调查和不合格产品的处置。
o 需要时，在生产过程变更时提供专业指导。
o 对于那些监督或管理员工的人员，如适用，负责确保下属遵循与健康，安全和环境实践相关的所有公司指南，以及所有需要的资源都是可用的，且状况良好
o 负责将业务相关问题或机会传达给下一级管理层。
o 负责确保个人和公司遵守联邦、州、地方和公司的所有法规、政策和程序。
o 执行其他必要的职责。
o Monitor all FGQA quality assurance functions.
o Establish and maintain appropriate documentation as required for Quality Assurance activities and the Quality Documentation Systems.
o Develop statistical sampling plans and perform process capability studies.
o Implement process control systems and provide technical support to process validations.
o Finish new test method protocol and report.
o Provide QS support in Product transfers and new products development.
o Assist in training new engineers, train technician and supervisors in process changes.
o Perform Complaint analysis investigation as needed.
o Participate in process/quality improvement projects.
o Support COGs initiatives.
o Responsible for following and administering safety.
o Compliance with safety policies and procedures.
o Follow J &J and Ethicon Records Management Policies for Convenience information, Records Retention Schedules, Training and Education, Document Hold Notices, Records Cleanout, Inactive Records and Information Management, Vital Records and the third-party vendor if applicable.
o Assist, review & approve non-conformances investigations & non-conforming product dispositions.
o Provide as needed, subject matter expert feedback on manufacturing process changes.
o Responsible for communicating business related issues or opportunities to next management level.
o Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
o Performs other duties assigned as needed.
岗位要求：
? 化学、工学或药学等类似学科学士及以上学位优先考虑。
? 3-5年以上工作经验或表现。
? 医疗器械行业或制药领域的经验优先。
? 六西格玛绿带或黑带优先。
? 流利的英语。
? 具备一定的GMP/ISO13485 知识。
? 良好的沟通能力和团队合作。
? Bachelor's degree and above in chemical, mechanical, pharm or similar preferred.
? 3-5 years related work experience or demonstrated performance.
? Experience in medical device or pharm industry preferred.
? Six Sigma Green Belt or Black Belt preferred.
? Fluent in English.
? GMP/ ISO knowledge preferred.
? Good communication skill and teamwork spirit.