南平招聘

Principal Duties and Responsibilities

• Act as contact window between global and local operation company, lead team to manage and implement JJMS Product Remediation activities to compliance with China regulatory, JNJ policy and LOC quality management system requirement.

作为全球总部与本地公司的接口，负责领导整个补救团队管理和执行JJMS产品补救措施以符合中国法规、JNJ 政策及本地质量管理体系的要求

• Join workshop, procedure and forum to field action surveillance with health authorities, global and APAC

参与卫生主管当局、总部、亚太区域的关于现场行动法规流程讨论、分享等；

• QMS management and maintenance for Document Control, protocol, NC case and CAPA support to remediation handling.

补救处置相关的文件管理、不合格事件、纠正预防措施的质量体系管理及维护

• Traceability claim system management in FDA

药监追溯申报系统管理

骨科工具质量管理

切实履行公司HCC，财务，安全和环境政策

• Fulfill other tasks assigned.

主管指派的其他工作

Basic Requirement

• Bachelor degree or equivalent experience related to this position, degree on pharmaceutical, medicine, medical device, engineering or electronic related subjects.

本科以上学历, 药学，医学，医疗器械，机械，电子等相关专业。

• Strong ownership and ability to meet ongoing deadlines

强烈主人翁意识及时间紧迫感；

• Managing relationships, influencing and negotiating skills

强有力的沟通影响能力；

• English fluent in reading, writing, oral, listening.

流畅的英文听说读写能力。

• 5 years’ or above work experience in quality or regulatory.

质量或法规方面5年以上工作经历。

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