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: Assistant Quality Manager-Channel Quality Service
Department: Quality & Compliance
Principal Duties and Responsibilities
Distributor Life Cycle Quality Management经销商全生命周期质量管理
1. Total take responsible for E2E channel quality management under two invoice policy environment. Make sure all activities are compliance with China regulatory, Franchise and global policy, ISO 13485 and local QMS requirements. Support business development under compliance requirement.
在两票制环境基础上优化端到端渠道的全生命周期质量管理体系，确保其能满足中国经营法规、强生总部和母公司，ISO13485的要求及本地质量管理体系要求基础上帮助业务合规快速发展。
2. Total take responsible for MD exclusive distributor quality management and enhancement.
全面负责全国总代的质量管理与改进；
3. Take responsible for annual channel qualification plan, include but not limit to on-site visit, self- assessment etc.
制定和执行年度的经销商质量评估计划，包括不限于适当的现场评估， 自查等。
4. Lead channel quality service team to complete all qualification activities on tracking. Make sure qualification close on time and meet annual quality objectives.
领导团队完成经销商现场审核，发现项追踪及确保经销商有效关闭，进行经销商质量自我评估并确认回复率不低于计划；
5. Join in or lead channel compliance project if applicable.
负责渠道相关项目质量合规工作；
6. Customer Focus and compliance base. Provide fast and effectiveness quality support to channel customs.
以客户为中心，合规为基础，及时提供渠道质量支持；
- Provide external customers (i.e. CM, sales) quality support.
及时为内部客户（如渠道管理，事业部等）提供质量管理的要求。
- Provide external customers (i.e. EXD, hospital) quality support, i.e. first operation application, inquires.
及时为外部客户提供合规的质量支持，如首营、质询等
- Provide quality training, regulatory consultant, technical inquires to customers.
为各部门质量相关的项目提供支持，包括培训、协调和专业支持等。
- Document control to compliance with China regulatory, Franchise and global policy, ISO 13485 and local QMS requirements.
负责经销商质量管理的文件控制和文档管理，确保符合中国经营法规、强生总部和母公司，ISO13485的要求及本地质量管理体系要求。
- Change Control Management
经销商质量管理文件的内容更新。
- Document control Management
经销商质量管理文档的保存、分类。
- Data Analysis
经销商质量管理数据分析。
？ Other responsibilities defined in written procedures.
流程中规定的其它职责。
1. Bachelor degree on pharmaceutical, medicine, medical device or related subjects.
本科或本科以上学位，医学或工程技术等专业优先考虑。
2. Good business insights
具有良好的商业洞察力
3. At least 5 years’ experience in quality compliance or related areas in medical device or pharmaceutical industries.
至少5年以上和质量相关的工作背景，医药或医疗器械行业优先考虑。
4. Excellent communication skills and leadership, good presenting and training skill.
出色的沟通和领导能力，良好的演讲和培训技能。
5. English fluent in reading, writing, oral, listening.
英语能够流利的听、写和口语。
6. Familiar with routine operations of computer and software.
熟练操作个人电脑，包括数据分析相关的应用技能。
7. Take travel over 30%.
承受30%以上的差旅。
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