Sr. Commercial Quality Control (QA) 上海

月薪： 1-1.5万/月

该公司所有职位
  • 3-4年经验
  • 本科
  • 招1人
  • 11-09 发布
  • 五险一金
  • 补充医疗保险
  • 免费班车
  • 专业培训
  • 年终奖金
  • 弹性工作
  • 定期体检

职位描述

职位描述： BASIC ROLES OF THIS POSITION:This position will include but not limit to the following roles: Document management aligned with global and local quality system; Promotional and advertisement materials review/approvals for both MD/IVD and non-IVD products; advert events (AE), customer feedback (CF), field action (FA) and recall tracking process and communications; Advertisement submissions and AE/FA reports to CFDA and follow-ups; Internal and external auditing on commercialization organizations, distributors and suppliers.ESSENTIAL DUTIES AND RESPONSIBILITIES:The incumbent will also be responsible for, but not limiting to the following duties:1Support quality supervisor/manager to develop, maintain and update quality manual, quality plan, quality procedures and instructions2Conduct internal audits & TPP audits and accommodate external audits; implement and monitor corrective/preventive actions and escalate if necessary3Coordinate adverse event and product corrective action reporting activities to CFDA4Monitor trend of customer complaints based on the analysis of customer feedback and coordinates the follow up action within cross-functional team5Review and approval advertisements/promotional materials including preparing package submissions and communications with CFDA.6Work with individual divisions to provide necessary support to dealers and customers for quality system and regulatory complianceWORKING RELATIONSHIPS AND CONTACTS:1External contacts for this position include CFDA officials, dealers, notify body auditors and users/customers2Internal contacts include all China staff members as well as quality/regulatory staffs from headquarter or other regionsSUPERVISION RECEIVED AND GIVEN:The incumbent of this position is responsible for his/her own work. Only new work is reviewed before issue, all other work is handled independently, reporting status to quality supervisor/manager. Some work requires analysis and use of initiative and independent judgment, but most assignments are specific and well defined.ESSENTIAL QUALIFICATIONS:EDUCATION: Degree holder in science, engineering, quality or relevant disciplineLANGUAGE: Good English and Chinese language skillsCOMPUTER: Good MS office computer skill (Excel, Word, PowerPoint)EXPERIENCE: Two years working experiences in quality related areas with science, engineering, quality or relevant discipline is preferred.FUNCTIONAL COMPETENCIES:1Have knowledge in ISO 9001 and experience in quality system auditing is preferred2Excellent communication skill, maintain frequent contact with internal and external contacts to ensure positive outcomes3Willing to focus on detailed routine work4Shows respect for all team members5Begins learning the company businesses and products and how own function impacts business results6Learns customer business needs and takes action to meet those needs7Learns to analyze business processes and customer requirements8Continuously learns from experiences, particularly non-routine challengesTRAVEL REQUIREMENTS:This position may require business traveling in a fewness situation.WORK ENVIRONMENT:This position functions in a general office environment. 职能类别： 医疗器械生产/质量管理 关键字： QA Commercial QA Quality

联系方式

上海市

公司信息

美国贝克曼库尔特公司是全球生命科学仪器、实验室系统及配套产品供应的领头羊。公司致力于实验室的工作流程向简单化和自动化方向发展，其业务覆盖了全自动实验室的解决方案、离心系统、血液分析以及快速诊断系统等诸多产品，著名的pH计和分光光度计就是由贝克曼库尔特公司创始人、美国国家发明家贝克曼博士于1935年和1941年发明的。 在过去的80年中，公司以不断向生物医学研究、药物开发和临床诊断领域的科学家和医务工作人员提供简单化、自动化和创新的解决方案为己任，从一个小小的酸度计的生产开始，发展到一个拥有几十种产品、服务遍布120多个国家、年销售额已超过37亿美元的跨国公司。公司在中国设有一个工厂、四个分公司和覆盖各个主要省份的销售和技术服务体系。 At Beckman Coulter, we are dedicated to advancing and optimizing the laboratory. For more than 80 years, we have been a trusted partner for laboratory professionals, helping to advance scientific research and patient care. We have a vital role: our focus on innovation, reliability and efficiency has led us to become the partner of choice for clinical, research and industrial customers around the globe. Diagnostics Beckman Coulter Diagnostics is devoted to helping healthcare professionals deliver better patient care – our instruments are found in hospitals and other critical care settings around the world. We produce information used by physicians to diagnose disease, make treatment decisions and monitor their patients. The combination of our scalable product portfolio with our automated and integrated data management systems allow healthcare professionals to achieve productivity in their organizations, which leads to better patient care. Life Sciences Beckman Coulter Life Sciences delivers innovative and trusted scientific solutions across the globe for laboratory customers in a wide variety of settings: universities, government, biotechnology and pharmaceutical companies, hospitals, and commercial laboratories. By innovating new processes and technologies, we’re challenging conventional wisdom to develop the best, most widely trusted laboratory solutions available in the market today. Together, both operating companies deliver innovative, reliable and efficient research and diagnostic solutions, advancing science and healthcare across the globe. Here's what you'll find: 1. We’re a growing company, and part of Danaher – a global leader in science and technology. 2. The Danaher Business System, the common operating system that shapes strategy, focuses execution, aligns our people, and creates tremendous value for customers. 3. Tools for your personal development and career development. 4. Comprehensive rewards. 5. A scientific/technical environment that is always looking for new ideas. 6. A global company, with opportunities to work with people across the country or around the world.

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