刘文娟

刘文娟 Email and Phone Number

质量主管
刘文娟's Location
Wuxi, Jiangsu, China, China
About 刘文娟

本人毕业于扬州大学,自动化专业,英语六级(听说读写流利),毕业后一直在外资企业负责质量管理的工作,有将近十年的质量管理经验,做过NPI导入阶段的QE,PQE,CQE以及后来的部门质量主管,在质量主管岗位有近四年的管理经验,熟悉ISO9001,ISO13485以及FDA QSR820质量管理体系。负责过的客户主要有美敦力,西门子,GE医疗,联影,东软,迈瑞等,包括各阶段品质问题的处理以及客户稽核主导,与客户建立友好的合作关系,不仅得到了老板的认可也得到了各个客户的认可和信任。

刘文娟's Current Company Details

质量主管
刘文娟 Work Experience Details
  • Leoni Cables (China) Co.,Ltd
    Quality Supervisor
    Leoni Cables (China) Co.,Ltd Oct 2017 - Aug 2018
    Changzhou, Jiangsu, China
    Responsibilities & Achievement: 1. Familiar with ISO9001, ISO13485 quality management system and its operation; 2. Familiar with the lean production management system, continue to participate in the company's lean improvement at all stages, and can be applied to actual work, timely identify potential improvement points and effectively implement, saving a lot of cost for company.3. Set quality goals and can manage teams(5 BUs: Medical, Industry, Robotics, Fiber , High Speed Communication and IQC ) to achieve goals. 4. Arrange the work for inspectors, effectively manage the work efficiency and inspector utilization of the five BUs (Medical, Industry, Robotics, Fiber , High Speed Communication) and Incoming Quality Inspection(IQC), and improve the inspection efficiency and inspector utilization rate of each BU.5. The application of quality control techniques and statistical techniques to perform analysis and improvement of the process abnormal quality, guarantee the continuous improvement in quality.6. Train the inspection and testing capability for inspectors; Train the line leader and inspectors to masters the PDCA analysis tool and applies it to the actual work;7. Responsible for customer audit, internal audit, external audit(such as SIEMENS,United Imaging...), summary the audit issues and suggestions, using PDCA method to analysis the root cause of the issues and provide improvement plan; 8. Customer complaint handling, customer complaint issue investigation, analysis and improvement, skilled use of 5why, fishbone diagram, flow chart, IS-IS NOT and other analysis methods, formulate corrective / preventive measures, and verify the effect; Can solve the complaints fundamentally.9. Be familiar with five core tools (PPAP/PFMEA/CP/SPC/MSA), and be able to make use of them, responsible for making quality related documents;10. Analyze and judge the product, potential risk and product quality deviation, organize and issue corrective and preventive actions;
  • 常州莱尼电气线缆有限公司
    质量主管
    常州莱尼电气线缆有限公司 Oct 2017 - Aug 2018
  • 常州莱尼电气线缆(中国)有限公司
    质量主管
    常州莱尼电气线缆(中国)有限公司 Oct 2017 - Aug 2018
    中国 江苏 常州
  • Jiangyin Sinbon Electronic Company
    Quality Supervisor
    Jiangyin Sinbon Electronic Company May 2013 - Sep 2017
    Jiangsu Jiangyin
    Responsibilities & Achievement: 1. Familiar with ISO9001, ISO13485, FDA (QSR820) quality management system and its operation;2. In charge of the implementation of quality system , and supervise the implementation of quality goals and achieve;3. Responsible for product quality control and process improvement from sample stage to mass production, to improve product quality, and ensure new product development meets customer requirements;4. The application of quality control techniques and statistical techniques to perform analysis and improvement of the supervision process abnormal quality, analyze the reason of failure in the field and make the improvement plan and supervise the implementation, to ensure that the process is effective and constantly optimized and improve the qualified rate of products;5. Responsible for customer audit(e.g: Medtronic, GE Healthcare,United Imaging, Neusoft,NOX-Medical.), internal ,external audit and FDA audit, summary the audit issues and suggestions, analysis the root cause of the issues and provide improvement plan;6. Organize department personnel to conduct procedure document & Failure Analysis Method & three party audit & report writing, and prepare training plan, guide the implementation and supervise the result;7. Customer complaint handling, customer complaint quality issue abnormal investigation, analysis and improvement, skilled use of 8D/5why, fishbone diagram, flow chart, IS-IS NOT and other methods, formulate corrective / preventive measures, and verify the effect;8. Conduct weekly quality meetings and drive quality improvement in all relevant departments; 9. Be familiar with five core tools (PPAP/PFMEA/CP/SPC/MSA), and be able to make use of them, responsible for making quality related documents;10. Analyze and judge the product, potential risk and product quality deviation, organize and issue CAPA corrective and preventive actions;11. Establish good communication with customers and deliver customer requirements;
  • Suzhou Fushunhong Electronic Company
    Customer Service Supervisor
    Suzhou Fushunhong Electronic Company May 2012 - Apr 2013
    Suzhou, Jiangsu, China
    Responsibilities & Achievement: 1. Handling customer complaints, ensure customer complaints are reported and taken containment actions in timely. Organize the internal departments to analysis and solve customer complaints.2. Lead customer plant audit or visit, according to customer requirements, coordinate the internal department to prepare the related information and production schedule , follow up customer finding and ensure the finding can be closed in timely.3. Be the key point of contact window for customer with regards to quality matters, handle and coordinate all customer claims with internal relevant department , assure fast response in accordance to customer needs and requirements, build good relationship.4. Lead 8D activity to ensure good root cause analysis and take corrective / preventive actions , carry out verification of effectiveness of actions , provide 8D report to customer timely.5. Responsible for establishing good communication and cooperation with customers, timely and actively feedback information, continuously improvement of the quality level in order to exceed customer expectations. Actively and quickly handle customer complaints, the management statistical analysis of the customer quality data for continuous improvement.6. According to customer complaints situation to take containment action ,such as onsite support , sorting , confirm for customer return part etc.
  • Kunshan Wistron Group
    Aqm Engineer
    Kunshan Wistron Group Feb 2008 - Apr 2011
    Jiangsu Kunshan
    1. Responsible for summary all kinds of information from customer, and feedback the status to customer on time, meantime, submitted the information to department head.2. Responsible for handling customer complaints in the world (Asia, North America and Europe), finishing out in the form of 8D, CAR report and feedback to customer.3. Coordinate the functions of the department and responsible for handling customer return, coordinate to analysis the root cause, and timely feedback to the department head and clients.4. Responsible for the quality issues feedback from customer if can be effective preventive and improvement in the factory, tracking the prevention and correction and verification.5. Provided regional service and support for customers around the world (eg: Send out the materials, components spare parts to customers in time; Arrange factory senior engineers to field site to provide services and support).6. Responsible for all listing Notebooks process and quality issues, including the model’s first production to the mass production till shipped out.7. Responsible for customer on-line audit, hold regular review meeting with the customer to discuss factory quality issues, report the quality of the recent situation and major issues to customer. 8. Timely follow up the progress of the manufacturers handling the materials (LCD HDD ADT, LCD Cable, etc...) quality problems, as well as the use of conditions in the factory, and feedback the progress and use status to customer;10. Responsible for the CCC, EICC, and other relevant certification and audit, send out the certification required information and on-site audit reports to customer in time.11. Familiar with the use of quality management tools and methods, such as the seven QC practices, in order to better control the quality, cover the problems in the factory, do not flow to the hands of the client and end user.

刘文娟 Education Details

Frequently Asked Questions about 刘文娟

What is 刘文娟's role at the current company?

刘文娟's current role is 质量主管.

What schools did 刘文娟 attend?

刘文娟 attended Yangzhou University.

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