招聘企业：常熟某日用品有限公司
- 汇报对象：总经理
- 下属人数：5人
- 所属行业：原材料及加工所属部门：质量部
- 企业性质：外商独资·外企办事处企业规模：50-99人
- 工作地点：常州发布日期：2015-03-20
岗位职责：
Implement and sustain a FDA compliant quality system.
Implement and maintain a Quality improvement process including establishing multi-year targets for achieving the company's overall strategic quality objectives.
Drive the development of quality related policy deployment objectives and action plans.
Provide recommendations for the identification and selection of quality improvement projects designed to achieve facility quality objectives.
Monitor and analyze effectiveness of quality system.
Monitor and report on quality metrics and progress toward quality goals including internal, incoming, and external quality.
Analyze internal quality defect data to define and resolve root causes.
Provide "expert" level knowledge, training and consulting in Quality Engineering related tools.
Manage quality processes and functions including but not limited to Nonconforming Material, CAPA, Incoming, Metrology, Calibration, Product Hold, Product Release and Temporary Deviations.
Manage, train and direct staff.
Support the achievement of facility financial objectives.
Identifies and implements metrics that provide quality and compliance visibility.
Drives data analysis of quality performance to identify high priority issues relating to safety, complaints and customer satisfaction.
Enables rapid and effective correction of quality problems in a manner that prevents recurrence.
Evaluates compliance risks and assists in development risk mitigation strategies.
Supervise and mentor quality assurance department employees, which may include interviewing, training, directing, disciplining, and reviewing employees.
Understanding of EU/FDA and Health Canada regulations for general products.
岗位要求：
- 学历要求：本科性别要求：男
- 语言要求：普通话专业要求：不限
- 年龄要求：30-45岁工作年限：5年
任职资格的具体描述：
Experience in FDA /Ethical Audit/ISO/BRC inspections is required.
CQE or CQM and CQA certification is preferred.
A working knowledge of FDA Quality System Regulations, ISO 9001, ISO 14001, ISO 13485:2003, Medical Devices Directives (EU and USA) EU cosmetic regulations, ISO 22716, BRC is required.
Process validation experience is required. Equipment / Instrument qualification experience is required. A knowledge of process controls, control plans, and risk management tools is required.
Six Sigma certification (Green or Black Belt) is preferred.
Lean sigma, six sigma and/or other quality tools knowledge and experience is preferred. Able to lead projects and demonstrates competency utilizing these tools.
Strong analytical skills with emphasis on statistical analysis, pareto, structured problem solving.
Strong computer skills is required.
Ability to effectively communicate and present at all levels and across the organization is required.
Ability to communicate verbally and in written form in Chinese and English is required.
Excellent skills in managing subordinates and strong interpersonal skills are required.
Must be able to handle multiple tasks/projects and manage priorities accordingly.
Strong awareness of technical standards required in a regulated industry.
EDUCATION AND/OR EXPERIENCE:
College degree or equivalent experience required.
5+ years of experience in Quality Assurance or Regulatory Affairs, medical device or drug experience is required.
Successful record of managing people and projects.
2+ years leadership experience (People development, written and verbal communications skills, action/results oriented, impact and influence).
薪酬福利：
- 职位年薪：15-20万薪资构成：基本薪资
- 年假福利：国家标准社保福利：国家标准
- 通讯交通：不确定
补充说明：
企业介绍：
公司厂房建筑面积超过8000平方米, 分为上下两层,除了部分仓库,所有工作区域均有空调.公司生产口腔卫生用品为主的日用品，为全球领导品牌，产品主要出口到欧洲、美国和日本等区域。主要产品为牙线, 还有少量口腔清新颗粒,口腔清新喷剂,蜡片,假牙盒,牙刷,舌刮等。