自贡招聘

Overall Introduction:
To support the LifeScan China in its efforts to ensure compliance with all relevant regulations and quality system requirements governing the importation and sale of LifeScan products.
支持LifeScan 中国事业，确保符合LifeScan产品进口和销售的所有相关法规和质量体系要求

Major Responsibilities:
1. Quality Systems – Training
质量体系-培训
Maintain quality system training records for China, including filing official training records and performing data entry into the training records management system
维护中国的质量体系培训记录，包括将正式培训记录归档，并将数据输入到培训记录管理系统中
Ongoing support of the Quality System Training System
持续支持质量体系培训体系
Provide Quality System support during internal and external audits
在内部和外部审核期间提供质量体系支持
Lead Quality System training for China
负责中国的质量体系培训
Assist with the effective deployment of the Quality System in China
协助质量体系在中国的有效部署

2. Quality Systems – Document Control
质量体系-文档控制
Participate in Quality System Improvement initiatives and projects representing LifeScan China
代表LifeScan参与中国的质量体系改进计划和项目
Support the management of the Quality System procedural documents including creation, revision and implementation of controlled documents required as part of the LifeScan Quality System for use in China
支持质量体系程序文件的管理，包括在中国使用的LifeScan质量体系所需的受控文件的创建、修订和实施
Maintain and implement communications to increase awareness of process changes and procedural updates
维护和实施沟通工作以提高对流程变更和程序更新的认识
Train and provide support to LifeScan China employees on the document system
提供与文档系统相关的培训和支持LifeScan中国员工
Provide Quality System support during internal and external audits
在内部和外部审核期间提供质量体系支持

3. Metrics
分析指标
Use statistical methods, quality tools and reports to continuously improve process capability
使用统计方法、质量工具和报告去持续优化流程
Provide metrics, support goals and initiatives and provide information to review forums as require
提供指标、支持目标和计划，并根据需要向审查会提供信息

4. Issues Identification and Escalation
问题识别和上报

Troubleshoot and escalate issues as required
根据需要排除难题并上报问题
Assist in determining root causes of issues and develop corrective actions and recommendations
协助确定问题的根本原因并制定纠正措施和建议
Suggest process and software changes when appropriate
适当时提出流程和软件上的变更

5. Distribution
流通分销

Support the LifeScan China Distribution Partners on all Quality Related Issues
在所有与质量相关的问题上支持LifeScan中国分销合作伙伴
Partner with LifeScan Global Distribution Quality Team
与LifeScan全球分销质量团队合作

6. Compliance
合规
Support MDRs (Medical Device Reports) reporting including but not limited to:
支持MDR（医疗器械报告）报告，包括但不限于：
Compile information for MDRs. Perform searches for reportable Malfunctions within the complaint management system.
编译MDR信息。在投诉管理系统中搜索可报告的故障
Maintain the department’s MDR filing and tracking system including correspondence between LifeScan, MHW and device manufacturers.
维护部门的MDR归档和跟踪系统，包括LifeScan、MHW和设备制造商之间的通信

Monitor and track reportables and investigations.
监控和跟踪报告和调查
Assist with correspondence with MHW regarding MDPRs.
协助与MHW的通信（与MDPRS相关）
Attach correspondence to cases within complaint management system.
将通信内容附在投诉管理系统内
Prepare Initial and Final MDRs after determination by LifeScan’s PMS & Vigilance Team
由LifeScan的PMS和审查小组确定后，准备MDR初稿和最终版
Track reporting times and investigation results.
跟踪报告时间和调查结果

7. Supplier Quality
供应商质量
Partner with LifeScan Global Supplier Quality Team to ensure all local suppliers are captured on the LifeScan Global Approved Supplier List and removed as required
与LifeScan全球供应商质量团队合作，确保所有本地供应商都被纳入LifeScan全球批准的供应商名单，并根据需要删除

8. Recall Management
召回管理
Develop Recall Strategy, to execute Field Actions. Develop Initial and Final recall notices and submit to appropriate Notified Bodies on behalf of LifeScan
制定召回策略，执行现场行动。制定初步和最终召回通知，并代表Lifecan向适当的通知机构提交

9. Aftersales Management
售后管理
Develop and implement aftersales service strategies, manage customer complaint, product return/exchange and other aftersales services.
制定及执行售后服务策略。管理客户投诉、产品退换及其他售后服务。

Qualifications:
With a bachelor’s degree (or above) in the medical laboratory science (ecsomatics), or has the Junior Inspector Certificate.
具有检验学相关专业大学或以上学历，或者具有检验师初级以上专业技术职称。
Experience within an ISO 13485/ISO 9001 environment preferred
拥有ISO 13485/ISO 9001环境经验者优先

微信分享