職位描述
Job Description
Job Title : Senior Quality Specialist / 高級質量專員 （質量投訴處理）
Department : QA
Job Location : 上海
Report to : Quality Manager
Subordinate : none
POSITION SUMMARY職位概要
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.
主要負責客戶投訴處理，需要和制造工廠、本地銷售和市場的團隊進行合作，完成事件調查并反饋給客戶；同時，需要協助其他質量人員一起維護質量體系的及時、有效，為公司業務的成功、持續和競爭優勢創造更多的價值。
KEY RESPONSIBILITIES主要職責
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,
處理客戶投訴，包括但不限于：投訴信息的系統錄入、與制造工廠\銷售\市場人員的溝通、反饋給客戶；
2. Maintain the complaint database, consolidate, trend, analyze, summarize and report customer complaints/feedback etc.;
維護投訴數據庫，整理、跟蹤趨勢、分析、總結并報告客戶投訴或反饋信息；
3. Maintain the customer-facing related quality system;
維護客戶投訴相關的質量體系；
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;
協調本地銷售和市場團隊的業務需求，傳遞給制造工廠；特別是對于產品質量早期預警或熱點問題，需要協調和帶領事件的調查；
5. Conduct the complaint related training to the respective Business Unit; and participate the business related customer visit and field activities;
開展對應業務部門的投訴相關培訓；參與業務相關的客戶拜訪以及其他現場活動；
6. Other related work assigned by the Manager.
其他由經理指派的工作
SKILLS AND ABILITIES能力要求
1. Fluent in spoken and written English;
熟練的英語說、寫能力
2. Good communication & presentation skills;
良好的溝通、表達技能
3. Teamwork & collaboration;
團隊合作和組織協調能力
4. Drive for results and action oriented with a high sense of urgency.
以高度的緊迫感推動結果和行動
DESIRABLE
1. College degree or above in Science discipline;
大專及大專以上學歷
2. At least 3 years quality assurance experience, prefer the pharmaceutical or medical device industry;
3年及以上質量保證相關的工作經驗，制藥和醫療器械行業優先；
3. Relevant experience in customer facing, complaint management, failure investigation, corrective & preventive action, and document & quality records management;
面對客戶相關經驗、投訴管理、事件調查、糾正和預防措施、文件記錄管理相關工作經驗；
4. Familiar with the CNDA quality system requirements, e.g. AE reporting, recall regulation, labeling requirements for the imported medical devices etc.;
熟悉國家藥品監督管理局相關的質量體系要求，例如，不良事件上報、產品召回、進口產品貼標要求等；
5. Knowledge in ISO 13485:2016, US FDA QSR will be an advantage;
了解ISO 13485:2016；最好是了解美國FDA的質量體系法規要求；
6. Good English communication skills, computer skills, excel, Access, PowerPoint etc.
良好的英語溝通、計算機、Excel和PowerPoint技能
Travel Frequency
<25%
