杭州招聘

1、负责公司医疗质量管理体系的建立，组织、推动质量管理体系推行、实施与持续改进；

2、负责对检验标准的制定、修改、定期评审，检查标准执行状况及有效性；

3、主导质量分析、编制质量控制文件，设计质量控制卡,确定质量控制点；

4、协调相关部门对质量问题进行分析，并监督改善措施的执行情况和效果；

5、运用质量分析工具对产品质量状况进行分析，负责产品相关质量文件和记录的维护和控制；

6、跟踪医疗器械主管当局审核、第三方审核和客户审核；

7、产品注册、认证及相关事宜。

岗位要求：

1、大专以上学历，本科学历优先考虑；

2、2年以上质量工作经验，有医疗器械或生物科技行业工作经验优先；

3、熟练运用各类质量管理工具、质量统计办法等，熟悉GMP、ISO13485、ISO9001质量管理体系，掌握质量检验的方法和手段，有外审经验，有建立公司质量管理体系能力者优先考虑。

4、有医疗器械产品注册工作经验优先；

5、工作积极主动，有较强的组织及统筹能力。

杭州睿丽科技有限公司成立于2015年，是一家专业从事体外诊断试剂、配套诊断仪器的研发、生产及销售的高新技术企业。公司坚持自主创新、攻克关键技术，现已发展成为国内领先、国际知名的创新免疫诊断领先型企业。
公司全面符合国际GMP要求，通过ISO13485质量体系认证；目前共有产业化基地近20000平米；配备了4000平方米的洁净车间，企业现有研发技术及管理人员200余人。
公司依托上述技术平台形成了***，心血管疾病、肿瘤、炎症、甲状腺功能、性激素、优生优育、毒检(药物滥用)等检验领域的丰富产品线。广泛应用于临床检验、危急重症、基层医疗、疫情监控、灾难救援、现场执法及家庭个人健康管理等领域。
睿丽科技一直放眼于全球市场的拓展，全面布局全球化的营销服务网络，为96个国家提供提供产品解决方案和技术支持。睿丽科技将持续投入研发创新，不断地向客户提供更方便、更快捷的精准诊断解决方案。聚焦创新诊断，避免同质化竞争，拿出特色产品。围绕国家关切，紧跟国家战略，致力于成为国际一流的体外诊断医疗企业。
睿丽科技有限公司热忱欢迎有志之士加入“睿丽大家庭”，共同成长，实干拼搏实现人生价值。
   Founded in 2015, Hangzhou Realy Technology Co., Ltd. is a high-tech enterprise specializing in the research and development, production and sales of in vitro diagnostic reagents and supporting diagnostic instruments. The company insists on independent innovation and overcoming key technologies, and has now developed into a leading domestic and internationally renowned innovative immunodiagnostic leading enterprise.
  The company fully complies with the international GMP requirements and has passed the ISO13485 quality system certification. At present, it has an industrialized base of nearly 20,000 square meters; it is equipped with a clean workshop of 4,000 square meters, and the company has more than 200 R&D technical and management personel.
Relying on the above-mentioned technology platform, the company has formed a rich product line in the field of infectious diseases, cardiovascular diseases, tumors, inflammation, thyroid function, sex hormones, eugenics and postnatal care, and drug testing (drug abuse). It is widely used in clinical inspection, critical illness, primary medical care, epidemic monitoring, disaster rescue, on-site law enforcement, and family personal health management.
 Realy Technology has been focusing on the expansion of the global market, comprehensively deploying a global marketing service network, and providing product solutions and technical support for 96 countries. Realy Technology will continue to invest in R&D and innovation, and continue to provide customers with more convenient and faster accurate diagnosis solutions. Focus on diagnostic innovation, avoid homogeneous competition, and come up with special products. Focusing on national concerns and closely following national strategies, we are committed to becoming a world-class IVD medical enterprise.
  Realy Technology Co., Ltd. warmly welcomes people with lofty ideals to join the "Realy Big Family" to grow together and work hard to realize the value of life.