• 5-7年经验
  • 本科
  • 招1人
  • 03-03 发布

职位描述

1. Maintain quality certification for various Amsino Medical Group entities, covering audits and documentation. 维护各种美诺医疗集团质量认证体系,包括审计和文件 2. Lead regular Management Review per Quality Policy and Quality Manual. 领导定期管理评审质量方针和质量手册 3. Develop company culture characterized by closed loop “Plan-Do-Check-Correction” by leading: 发展公司文化,遵循“计划-实施-检验-纠正”环节,以以下几方面为主导: - Timely policy documentation, training, and implementation. 政策证明及时记录,培训和实施 - (On a dotted line basis) BU-designated “Quality Coaches” to enforce quality execution and conduct self-audit. (虚线部分)成为指定业务单元的“质量教练”,负责质量检验和自审; - Monthly executive review of key quality metrics at all plants. 每月对所有工厂的关键质量度量执行回顾 4. Design system and mechanism to achieve Amsino’s targets in 设计相关机制实现公司以下目标: - Proactive Quality as supported by functional processes (including supplier qualification, manufacturing QC, and Engineering quality) for continuous improvement. 具有前瞻性的产品质量,会受到各方面的支持(包括供应商资格、生产质量管理、工程质量管理)以继续提高质量。 - Reactive Quality as evidenced by compliant complaint handling and product defect resolution. 质量检验,并提供相关证据以处理客户投诉及瑕疵产品 5. Train and develop a team of qualified Quality Coaches and Internal Auditors capable of cross-BU audits. 培训和发展团队质量合格的教练和内部审计师审计的能力 6. Quantify process capability by selectively measuring performance . 通过选择性表现测试量化过程能力 Qualifications: 任职资格: 1.Knowledgeable in ISO-13485 is a MUST, and ISO-14000, OHSAS18000, and CE Mark criteria,21CFR 820 regulations is preferable. 必须掌握ISO13485质量体系认证体系和ISO-14000,OHSAS18000和CE 标志标准,21CFR820法规更佳。 2. Communication, interpersonal, and motivational skills. 沟通、人际关系和沟通技巧良好 3. Disciplined in process design, documentation, and non-conformity analysis. 流程设计、文档和不合格分析能力强 4. Proficiency in verbal and written English and Chinese. 熟练的口头和书面英语和中文。 5. Capable of working with multiple business leaders across organizational boundaries. 能够处理多个商业领袖跨组织边界。 6. Progressive experience in manufacturing or other process quality for 5 years, 2 of which with people management exposure; 在制造业或其他质量领域有5年相关经验,2年管理经验 7.BS degree in Manufacturing, Industrial Engineering, Life Science. 制造、工业工程、生命科学本科学位, 8.Knowledgeable in ISO quality criteria and methodology. 熟悉ISO质量标准方法 9.Prior training and certification in Six Sigma (or Lean Sigma) methodology is strongly preferred. 有六西格码方法培训或证书为佳。 职能类别: 质量管理/测试经理(QA/QC经理) 医疗器械生产/质量管理

联系方式

上海市嘉定区高潮路555号

公司信息

Amsino Medical Group (AMG) is a leading provider of products worldwide for the health-care industry. An ISO 9001/13485 certified, FDA registered manufacturing firm of disposable medical products, AMG is headquartered in Pomona, California, USA. Established in 1993, it is privately held with manufacturing facilities both in the US and in China, employing over 2,000 people. Amsino’s products are mostly designed and developed in the US, manufactured and assembled at its manufacturing plants in China, and are distributed in the United States and more than 30 different countries. Amsino Healthcare (shanghai) Co., Ltd. is a subsidiary of AMG in China. There are four manufacture sites of AMG near Shanghai. Amsino is seeking following team players to join us. Comprehensive working challenges, sufficient career development and competitive remuneration package will be provided. 总部位于美国加州的美诺医疗集团,是全球领先的集研发、生产、销售为一体的跨国医疗集团公司。美诺医疗集团以提高人类医疗水准为使命,致力于改善和提高医疗器具的安全性和有效性,开发并拥有多项国际领先专利技术,生产并经销以感染控制、抗菌涂层和安全无针为核心技术的系列产品;并在国际医疗行业建立了领导地位和崇高声誉。 美诺医疗集团拥有十一家子公司,三大战略事业部门。 美诺医疗集团主要生产和经营六大系列产品:药品输送系统类、肠内营养输送系统类、麻醉和手术类、泌尿系列产品类、呼吸治疗类和病人护理产品类。美诺产品销往世界五十多个国家和地区。 美诺医疗集团积极致力于社区建设与慈善事业,多年来一直大力支持各种公益活动,赞助国际直接救济组织(Direct Relief International)10余年,各种项目遍及世界100多个发展中国家和地区。 美诺努力为员工创造振奋人心的工作环境,为公司拓展高回报的业务。因此,美诺引进最优秀人才并为员工提供全方位的薪酬激励政策,用于奖励员工在个人及公司业务发展的方面的贡献。 我们的薪酬结构包括具有竞争力的工资及其他奖励。同时提供包括医疗、养老、带薪假期等完善福利,并制定一系列方案用于帮助员工平衡工作职责与个人专业发展的关系。

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