Zhibin Li

Experience

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  Suzhou Electronic Products Test Institute

  Jul 1998 - Jun 2003

  Lab Manager

  I can understand and flexible use of ISO17025 to building the lab quality system with personal understanding. Unity of all laboratory staff, a reasonable allocation of their work to maximize their potential and expertise through effective communication and to build high performance teams, all the staff of the laboratory reflect the overall high-quality, high technology, high efficiency. In my management phase, the Ministry of the experiment showed unprecedented solidarity. The company develops with annually revenue increase 15% and equipment fault rate reduce 5% speed to increase benefits.Not only to learning the administrative knowledge, but also learning total quality management. I have learned ISO9001, ISO14001, ISO18001, ISO10012 and got the certificate. Through the quality system learning and application, issue the policy "quality, the eternal theme of survival, and the same principle when a Progressive. " in my group.Use my knowledge to developed and drafted 3 company standards for 2 companies. I have got the qualifications of employees have been standardized. Proficient using the knowledge of ISO9001 to establish a quality management system for two foreign companies. I also participated in the new product review work, as the membership of the assessment Group, presided over the new appraisal inspection. Свернуть

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  Suzhou Xinju Electronic Limited Company

  Jul 2003 - Dec 2003

  Quality Manager

  Response for quality management in whole company, using all kinds of quality tools to improve the product quality levelResponse for building the integration system with ISO9001, ISO14001, ISO18001 and passed certification body’s on site assessment.

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  Underwriters Laboratories

  Jan 2004 - May 2011

  Quality

  1.Response for building the lab quality system according to the requirement of ISO17025, to ensure the operation meet the requirement and maintain the CNAS, CBTL, OSHA, ANSI, SCC, NVLAP and IAS and other lab accreditation2.Response for manage the lab testing equipment according to ISO10012, ensuring that all lab testing equipment to meet the testing and certification requirements.3.Response for building the inspection body quality system according ISO17020, to ensure the system operation meet the CNAS and government special requirement4.Response for Lab document management, including laboratory documentation, release, and control and make sure the document system to meet the certification requirement. Follow up the certification bodies’ new requirement, to support the continue improvement.5.Response for new laboratory design and training support. Has been involved in the program that laboratory's quality system integration and improvement for acquired lab in U.S. Design the new lab with Lean and 6 Sigma in India, participate in the global commercial laboratory management information system construction, LIMS with Orcal.6.Response for the Suzhou company relocation project, using lean and 6 Sigma for the new labs building design and to ensure meet the Corporate and LEED green energy building requirements7.As the internal lead assessor response for perform the annually internal assessment according to the plan. Support the top managers to complete the management review with Performance Excellence Module8.As the company's internal training commissioner, participate in the training for new employees and the quality technologies and concepts training9.As a registered national quality engineers use quality tools to monitoring the quality system operation and provide quality advice to all departments10.As the business excellence office member, using Six Sigma tools for process change and quality improvement, driving the company's operational excellence Свернуть

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  3M

  May 2011 - Jul 2019

  Quality Regulatory & Operation Manager

  Operation Excellence1.Setup verification capability base on Business Strategy, from great beginning, balance the existing capability & capacity & cost.Covers NVH for Auto,Air cleaner,EMC,Purification for Home and Pharmaceutical,Microbe,Mask & Respirator.2.Charge the China HNTE program for 7 entities,review and balance the budget, RD investment & cost,head count,IP & sales.Take actions base on the operation data analysis.3.Building the digitization working place with lean operation,support the business & Transformation program.The key project such as SAP, LIMS, etc.4.Update Trade Secret database timely, create out the on site control plan,access management,compliance corporate requirement.5.Response for RD OPEX,covers RD investment & cost evaluation, warehouse & waste management,facility engineering & maintenance, EHS and other daily operation. Regulatory & Standardization1.Define the strategy in standard and affairs function to meet the business needs and tracing the industry direction. Maintain the relationship with standard organization.2.Product regulatory review and approve, it covers the product life LCM, review the new regulatory update and the impact.3.Building the enterprise standard system and implementation. Ensure the product with the enterprise standard meet the regulatory requirement.4.Coordinate and participate in the each national standard body, industry association, government and standard association activity, support the national standard, industry standard development.Quality Engineering1.Quality system implementation, it covers ISO9001,ISO13485,TS16949,ISO17025,GXP etc,support the BU for product certification, external assessment & other quality engineering needs.2.Support the NPI for quality review and action items.covers quality tools training&support (QFD,FMEA,APQP,PPAP,MSA,DOE,etc) and product validation & verification. 3.Quality function operation,such as document control, internal & external audit,CAPA,management review. Свернуть

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  China Quality Certification Center

  Jul 2019 - Oct 2020

  Business Excellence & Compliance Director

  Business Excellence1. Develop the new operation module, covers all sites & business, with customer insight to drive value stream studies, to identify the area of improvement.2. Define the improvement plan & objective & action. Training & share the good practice within company.3. Define the risk & opportunity with FMEA, define the problem solving plan and implementation with quality or six sigma tools.4. Leading the MOC process, training & support the change agent to drive the excellence result.5. Regularly financial analysis covers investment, cost, revenue and identify improvement opportunity, support the internal compliance assessment.6. Leading management innovation activities, Participate in scientific and technological innovationDigitalization Transformation(DT)Leading the DT program. Use visual, Kanban,VSM, Blockchain, AI, Security, IoT, Computing & other tools to building the new IMS.Compliance Management1. Quality Strategy. create out the strategy, perform the schedule and monitor the status.2. Quality System compliance with the ISO17025, ISO17020, ISO9001, ISO13485, TS16949 & other national standard or accreditation requirement.3. Quality Department Operation, it covers DCC, CAPA, IA, EA & customer auditor. perform the PT, QA activity, data analysis and risk assessment.4. Vendor Management, it covers vendor selection, classification, vendor evaluation & qualification, dynamic performance appraisal.5. Investment Management, charge asset LCM and balance the company finance status.6. Standardization, to participate each standard organization’s activity for standard release or revise.7. EHS management, create an EHS culture, ensure no major accident.8. Warehouse and Waste Management, charge of sample, consumable and dangerous goods warehouse, complete the collection and harmless treatment of electronic, hazardous, laboratory, waste water and waste gas, as well as relevant environmental and health impact assessment of the company. Свернуть

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  HUABI Group

  Dec 2020 - now

  Operation & Compliance Director

  Fully responsible for the compliance and operation of the group, mainly responsible for the management and operation of the quality department, product certification department, Research Institute and government relationship department