• 3-4年经验
  • 本科
  • 招若干人
  • 11-09 发布
  • 定期体检
  • 专业培训
  • 五险一金

职位描述

职位描述: 职位职责 (简要说明)?Ensures that the local Quality Management System meets current regulatory requirements and comply with local business operation;?Lead Development and/or Improvement of Quality system;?Improve and optimize the corrective action and preventive action system.主要工作内容/职责(列举清单)?Ensures that the local Quality Management System meets current regulatory requirements and comply with local business operation;?Ensures Cooperate policies are implemented within local SOPs within the local QMS as appropriate?Assist with development and/or Improvement of Quality System procedures and processes;?Assist with internal and supplier audit development, implementation, and execution;?Provide support to internal functions in the application, maintenance and improvement of medical quality systems and department specific processes;?Improve and optimize the corrective action and preventive action system for medical projects to ensure the compliance of FDA QSR820, ISO 13485:2003, etc.;?Responsible for managing 3rd party audit, regulatory compliance agency inspection;?Document control management for medical project;?Other tasks assigned.任职资格知识/教育程度?Bachelor’s Degree in Engineering, Science, or health-related field?Familiar with Quality system Improvement tools, such as 8D, fish bone, 5why,etc.经验/能力要求?3-5 years related work experience in Quality Management system, at least two years’ experience as quality system engineer or above.?Quality Systems development, implementation, and training experience?Experience with ISO 9001, TS 16949 system requirements and training, ISO 13485 is preferred.?Must be able to work independently and have ability to work with cross-functional teams?Extensive project management skills with the ability to work under tight timelines and able to multi-task?Must have an understanding of fundamental quality system processes for design, CAPA and manufacturing in a regulated industry.?Familiar with MS-OFFICE;?Good communication and team work;?Fluency in oral and written English. 职能类别: 医疗器械生产/质量管理 医疗器械研发

联系方式

江苏省常州市新北区长江北路西江路11号

公司信息

Medtronic is the global leading medical technology company. Headquarter is in Minneapolis, Minnesota in the United States. Medtronic was founded in 1949 by Earl Bakken and Palmer J. Hermundslie. Medtronic built the first battery-powered cardiac pacemaker in 1957 and the first implantable cardiac pacemaker in 1960,that paved the way for Medtronic’s dominance in globe pace-making technology. 美敦力公司目前是全球领先的医疗科技公司,总部位于美国明尼苏达州的明尼阿波利斯市。 美敦力成立于1949年,由Earl E.Bakken及Palmer J.Hermundslie建立。 美敦力于1957年制造出第一台便携式体外心脏起搏器,并于1960年制造出第一台可靠的可植入式心脏起搏系统。由此奠定了美敦力全球起搏技术领导者的地位。 Changzhou Kanghui Medical Innovation Co., Ltd. (“Kanghui”) is a leading developer of orthopedic products in China. Orthopedic implant materials are the main products, widely used in the field of human traumatic restoration and spinal deformity correction. In November 2012, Medtronic, Inc., the global leading medical technology company, announced that it has completed its acquisition of Kanghui, making it the first Medtronic business unit headquartered outside the United States. Located in Changzhou National Hi-Tech District, Kanghui has a rapidly increasing business performance. Kanghui has rapidly grown into an international medical device company with core competency, whose extensive sales and service network covers every province in China. It enters the international market as well and has sales in countries and regions like United States, Japan, EU, Latin America, Middle East, Southeast Asia, etc., providing the global patients with high-quality products and service. Kanghui has a good prospect of accelerating its globalization by leveraging the scale and expertise of Medtronic after the acquisition. It will achieve the leapfrog development and promote the improvement and advancement of local medical device industry. 康辉医疗是我国骨科行业的领先企业、国家重点高新技术企业、全国外科植入物和矫形器械标准化技术委员会委员单位。公司主导产品为骨科植入材料,广泛应用于人体创伤修复、脊柱矫形等治疗领域。2012年11月,全球领先的医疗科技公司美国美敦力公司(Medtronic, Inc.)宣布完成了对康辉的并购,从此,康辉作为首个总部在美国之外的美敦力业务部门独立运营。 公司总部位于常州国家高新技术产业开发区,占地面积120亩,建筑面积超过8万平方米,注册资本4.7亿元,总投资达8亿元,资产总额超过10亿元,公司经营业绩每年快速增长,品牌建设硕果累累,公司被认定为国家高新技术企业,公司产品被认定为“江苏省名牌产品”;2009年至2012年连续四年被《福布斯》评选为 “中国最具潜力企业50强”。 在国际化职业经理人团队的带领下,康辉正快速成长为具有核心竞争力的国际化医疗器械企业。目前,公司的销售服务网络已覆盖了全国各省、市、自治区,并全面进军国际市场,产品已进入拉丁美洲、中东、非洲、印度、东南亚、欧洲地区,为全球患者提供高品质的产品和服务。加入美敦力后,借助美敦力的品牌、渠道和技术优势,有助于快速实现康辉医疗的全球化愿景。根据美敦力的全球战略规划,在未来十年内,作为美敦力旗下的重要业务分支,康辉将在美敦力全球版图中占据更为重要的位置,实现跨越式发展,不断推动本土医疗器械产业的发展和进步。 更多公司信息请登录公司网站查看。有意者请将个人中、英文简历用电子邮件或传真发至本公司,注明应聘职位,谢绝拜访! 公司网址:www.kanghui-med.com E-Mail:h.k@kanghui-med.com

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