职位描述
Job Description
Job Title : Senior Quality Specialist / 高级质量专员 （质量投诉处理）
Department : QA
Job Location : 上海
Report to : Quality Manager
Subordinate : none
POSITION SUMMARY职位概要
This position is mainly responsible for customer complaint handling and he/she is to work together with the manufacturing plants, local sales and marketing teams, to complete the failure investigation and feedback to the customers. The position also support to maintain an effective and efficient quality system that creates customer value addressing elements critical to Business success, continuity and competitive advantage.
主要负责客户投诉处理，需要和制造工厂、本地销售和市场的团队进行合作，完成事件调查并反馈给客户；同时，需要协助其他质量人员一起维护质量体系的及时、有效，为公司业务的成功、持续和竞争优势创造更多的价值。
KEY RESPONSIBILITIES主要职责
1. Handle the customer complaint, including but not limited to: login the complaint information into TrackWise system, communication with manufacturing sites and sales and marketing, feedback to the customer,
处理客户投诉，包括但不限于：投诉信息的系统录入、与制造工厂\销售\市场人员的沟通、反馈给客户；
2. Maintain the complaint database, consolidate, trend, analyze, summarize and report customer complaints/feedback etc.;
维护投诉数据库，整理、跟踪趋势、分析、总结并报告客户投诉或反馈信息；
3. Maintain the customer-facing related quality system;
维护客户投诉相关的质量体系；
4. Coordinate the business need from local sales and marketing team with the manufacturing plants, especially to coordinate and lead the investigation to the early warning of the product quality or hot issue;
协调本地销售和市场团队的业务需求，传递给制造工厂；特别是对于产品质量早期预警或热点问题，需要协调和带领事件的调查；
5. Conduct the complaint related training to the respective Business Unit; and participate the business related customer visit and field activities;
开展对应业务部门的投诉相关培训；参与业务相关的客户拜访以及其他现场活动；
6. Other related work assigned by the Manager.
其他由经理指派的工作
SKILLS AND ABILITIES能力要求
1. Fluent in spoken and written English;
熟练的英语说、写能力
2. Good communication & presentation skills;
良好的沟通、表达技能
3. Teamwork & collaboration;
团队合作和组织协调能力
4. Drive for results and action oriented with a high sense of urgency.
以高度的紧迫感推动结果和行动
DESIRABLE
1. College degree or above in Science discipline;
大专及大专以上学历
2. At least 3 years quality assurance experience, prefer the pharmaceutical or medical device industry;
3年及以上质量保证相关的工作经验，制药和医疗器械行业优先；
3. Relevant experience in customer facing, complaint management, failure investigation, corrective & preventive action, and document & quality records management;
面对客户相关经验、投诉管理、事件调查、纠正和预防措施、文件记录管理相关工作经验；
4. Familiar with the CNDA quality system requirements, e.g. AE reporting, recall regulation, labeling requirements for the imported medical devices etc.;
熟悉国家药品监督管理局相关的质量体系要求，例如，不良事件上报、产品召回、进口产品贴标要求等；
5. Knowledge in ISO 13485:2016, US FDA QSR will be an advantage;
了解ISO 13485:2016；最好是了解美国FDA的质量体系法规要求；
6. Good English communication skills, computer skills, excel, Access, PowerPoint etc.
良好的英语沟通、计算机、Excel和PowerPoint技能
Travel Frequency
<25%
