主要职责:

1、 FDA PMTA 审核

2、 PMTA流程执行落地

3、 ISO13485、GMP品质体系建立、优化、落地

4、 客户审核及认证审核

Company: Shenzhen Smok Technology Co., Ltd

Private enterprises, the production of electronic cigarettes, independent brands + OEM, employees 5000 +

Duration: April 25-2022

Position: Deputy Director of Quality

Main responsibilities.

1、 FDA PMTA audit

2、 PMTA process execution and implementation

3、 ISO13485, GMP quality system establishment, optimization, implementation

4、 Customer audit and 3rd party certification audit

工作经历

Work history

(民营企业,电子烟行业世界第一,主要客户英美烟草、NJOY、悦刻等。雇员2万+)

主要职责:

1、体系部门负责人,战略、目标分解与达成,工作统筹管理,人员管理与能力培养;

2、负责客户审厂,监管机构审厂(FDA)、第三方机构认证审核及问题跟进;

3、ISO9001,ISO13485,ISO14001 , QC080000等体系的建立与维护,年度体系内部审核方案的策划及实施内审;年度体系管理评审的实施,体系的改进的策划和实施;

4、流程优化,重点质量管理流程梳理优化,独创8步法流程诊断与优化;

5、政府相关项目推动与达成,如政府质量奖评奖(卓越绩效评价)、智能制造能力成熟度评估;

6、进行新入职人员质量体系意识培训,体系内审员培训,汽车五大工具培训及导入、优化,品质体系意识宣传、质量月活动等。

Company: Shenzhen Smoore Technology Co.

(Private enterprise, world No.1 in the electronic cigarette industry, main customers British American Tobacco, NJOY, Yueh-Cheng, etc. 20,000+ employees)

Duration: September 2019 - April 2022

Position: Quality System Manager

Key responsibilities.

1, head of the system department, strategy, target decomposition and achievement, work co-ordination and management, personnel management and capacity development.

2, responsible for customer audit, regulatory agency audit (FDA), third party agency certification audit and issue follow-up.

3, ISO9001, ISO13485, ISO14001, QC080000 and other systems establishment and maintenance, annual system internal audit program planning and implementation of internal audit; annual system management review implementation, system improvement planning and implementation.

4、Process optimization, key quality management process combing and optimization, original 8-step process diagnosis and optimization.

5, government-related projects to promote and achieve, such as government quality award evaluation (excellence in performance evaluation), intelligent manufacturing capability maturity assessment.

6、To conduct quality system awareness training for new recruits, system internal auditor training, automotive five tools training and introduction, optimization, quality system awareness promotion, quality month activities, etc.

工作经历Work history

(德资公司,电动工具行业世界第二,主要产品为出口型手持式电动工具,户外园林工具,吸奶泵,电子针灸治疗仪。全球雇员5万,东莞公司2万+)

主要职责:

1、接待应对客户质量、环境、社会责任等体系审厂,接待第三方机构认证审核及问题跟进;

2、FDA 审厂准备,文件体系更新;

3、ISO9001,ISO13485,ISO14001 , QC080000等体系的维护优化,ISO45001体系建立,年度体系内部审核方案的策划及实施内审;年度体系管理评审的实施,体系的改进的策划和实施;

4、品质目标的统计和分析;

5、政府质量奖评奖项目推动;

6、进行新入职人员质量体系意识培训,体系内审员培训,品质体系意识宣传等。

Company: Dongguan TTI Industrial Products Co Ltd

(German-owned company, second in the world in the power tool industry, main products are export-oriented handheld power tools, outdoor garden tools, breast pump, electronic acupuncture therapy device. 50,000 employees worldwide, 20,000+ in Dongguan company)

Duration: January 2013 - September 2019

Position: Senior System Engineer

Main duties.

1、Receive and respond to customers' quality, environmental, social responsibility and other system audits, receive third party certification audits and follow up on issues;

2, FDA audit preparation, document system update;

3, ISO9001, ISO13485, ISO14001, QC080000 and other system maintenance and optimization, ISO45001 system establishment, annual system internal audit program planning and implementation of internal audit; annual system management review implementation, system improvement planning and implementation;

4、Statistics and analysis of quality objectives;

5, government quality award evaluation project promotion.

6、To conduct quality system awareness training for new recruits, system internal auditor training, quality system awareness promotion, etc.

工作经历Work history

(民营笔记本电脑、手机、显卡生产企业,主要客户:联想、TCL。雇员5000)

1、负责公司的ISO9001,ISO14001,QC080000等管理体系运行与维护;

2、文件体系优化、流程优化;

3、负责策划实施内审和管理评审主导客户调查、供应商管理体系的稽核与辅导。环保异常处理。建立环保管理标准等。

Company: Shenzhen Bitland Information Technology Co., Ltd.

Private notebook computers, mobile phones, graphics card manufacturers, the main customers: Lenovo, TCL. Employee 5000).

Duration: may 2011-January 2013.

1. Responsible for the operation and maintenance of the company's ISO9001,ISO14001,QC080000 and other management system.

2. File system optimization and process optimization.

3. Responsible for the planning and implementation of internal audit and management review to lead customer investigation, supplier management system audit and guidance. Abnormal handling of environmental protection. Establish environmental protection management standards and so on.

工作经历Work history

(日资公司,主要产品 汽车电子、刹车油缸,传感器,客户:天和,宝马、大众等。雇员3000)

主要职责:

1、负责ISO9001,ISO/TS16949,QC080000等体系的管理工作,建立和优化体系文件系统;

2、应对客户审核及调查和第三方审核,策划、实施体系内审和管理评审;

3、实施TS过程审核和FMEA,SPC,MSA等五大工具的运用和实施;

4、培训内审员,宣传员工质量意识等。

Company: Shen Zhen Aleph Electronics.

Japanese companies, the main products of automotive electronics, brake cylinders, sensors, customers: Tianhe, BMW, Volkswagen and so on. Employee 3000).

Duration: February 2008-May 2011.

Position: systems engineer.

Main responsibilities:

1. Responsible for the management of ISO9001,ISO/TS16949,QC080000 and other systems, establishing and optimizing the system file system.

2. should be customer audit and investigation and third-party audit, plan and implement system internal audit and management review.

3. The application and implementation of five tools such as TS process audit and FMEA,SPC,MSA.

4. Train internal auditors and publicize employees' quality awareness.

工作经历Work history

主要职责:

1、检验指导书制定,制程质量管理,异常及客诉分析与跟进改善(QE时);

2、负责对电子物料供应商的审核和问题改善跟进,包括质量管理体系ISO9001,环境管理体系ISO14001,有害物质管理体系QC080000的审核与改善辅导管理。

3、FGPT(富士康绿色产品专案)推动,集团各厂区、事业群、事业部QC080000体系审核与辅导改善。

Company: Foxconn Technology Group (Shenzhen Longhua Park headquarters).

Duration: July 2003, January 2008.

Position: QE, system engineer.

He worked as a quality engineer in Foxconn Technology Group WLBG and then transferred to the supplier quality responsibility Management (SQRM) Department of the Purchasing Office as a system engineer.

Main responsibilities:

1. Inspection instruction formulation, process quality management, abnormal and customer complaint analysis and follow-up improvement (QE).

2. Responsible for electronic material supplier audit and problem improvement follow-up, including quality management system ISO9001, environmental management system ISO14001, hazardous substances management system QC080000 audit and improvement guidance management.

3. FGPT (Foxconn Green Product Project) promotes the improvement of QC080000 system audit and guidance in all factories, business groups and business departments of the group.