Quality Engineer

招聘人数：1-2人 到岗时间：不限 年龄要求：不限 婚况要求：婚姻状况 Job Title: Quality Engineer
Department: Quality & Compliance
Job Title of Direct Supervisor: Assistant Quality Manager (QMS)


1. Principal Duties and Responsibilities
- Support the quality manager to maintain and improve quality system compliance in JJMC & JJMS as per ISO13485, J&J Quality Policy, and regulatory requirements, focused on below items: 支持质量经理按照ISO13485，J&J质量方针和法规要求维持和提高JJMS质量体系的符合性，侧重在以下方面：
- Document Control 文档控制
- Maintain JJMS QDM e-system as administrator; ensure the compliance of the system. 作为管理员，负责JJMS电子文档系统QDM的维护，确保系统的符合性。
- Issue the document; ensure all issued documents meet quality document policy requirements. 安排文件生效；确保所有生效文件满足质量体系文档方针要求。
- Coordinate the document periodical review and escalate any issue to direct supervisor. 协调文件定期审阅，有任何问题报告给直接主管。
- Record Control 记录控制
- Maintain quality record control procedure. 维护质量记录控制流程。
- Assist QMS manager with the implementation of GDP requirements. 协助QMS经理GDP要求在体系内的实施。
- Change Control 变更控制
- Maintain change control procedure. 维护变更控制流程。
- Track CCA case, complete the dashboard and report any overdue case to QMS manager. 跟踪CCA的状态, 完成报表并就任何过期的情况向QMS经理汇报。
- Provide summary for management review and/or sourcing visit. 为管理评审和/或母公司访问需要提供CCA汇总信息。
- Responsible for tracking related escalation events, collecting evidence to ensure they are under proper and effective monitoring. 负责相关上报事件的追踪，收集相应的证据确保该上报事件得到适当有效的监控。

- Other responsibilities defined in written procedures. 流程中规定的其它职责。
- Fulfill other tasks assigned. 其他指定的工作任务。



2. Basic Requirement, including Education and/or Knowledge and/or Training and/or key Relevant Experience required.
- Bachelor Degree on pharmaceutical, medicine, medical device or related subjects. 药学、医学、医疗器械相关专业本科学历。
- Good communication skills and leadership 良好的沟通和领导能力
- English fluent in reading, writing, oral and listening 流畅的英文听说读写能力
- Familiar with routine operations of computer and software 熟练操作计算机常用功能