艾康生物技术（杭州）有限公司是旅美留学博士创办的外商独资生物诊断公司，公司成立于1995年，现已通过中国GMP、欧洲CE、ISO13485三大国际权威认证和美国FDA注册，生产管理严格按照国际质量管理体系运行，保证了产品的高质量。
艾康依托中美两地人才技术优势，在生物诊断领域已形成完善的研发、生产和销售的产业化体系，为公司的可持续发展提供了强大的动力。
艾康产品覆盖体外诊断试剂、医疗器械、医疗电子三大产业，以高科技产品服务客户为中心，整合生物技术（BT）和电子信息技术（IT），通过研制快速、准确、方便的临床检测产品来促进对疾病的诊断，致力于为用户提供更方便、更丰富的床边诊断产品。公司已成功开发了艾科系列血糖仪、尿液分析仪、干式生化分析仪、血红蛋白分析仪、血脂分析仪等医疗器械及相应检测试剂、PCR检测试剂、酶联免疫检测试剂、胶体金检测试剂等100多种快速诊断产品，获得61项美国FDA文号、4项中国SFDA新药证书、72项中国SFDA医疗器械证书，131个产品的365个型号获得欧洲CE认证，产品畅销世界130多个国家和地区，成为全球***的生物诊断产品产业化基地之一。
艾康自成立以来，深谙人才是公司发展的***资源，一直实践着“用事业成就人才，用人才发展事业”的先进的人才理念，致力于打造企业吸引和发展人才的竞争优势。拥有一支朝气蓬勃，积极向上，勤奋务实，开拓创新的人才队伍！
公司的飞速发展、合理的经营管理制度、公平的人才选拔机制、良好的培训体系、优厚的薪酬及完善的福利为员工提供了广阔的发展空间！
About Acon
ACON Biotech (Hangzhou) Co., Ltd is a hi-tech enterprise founded by Doctors of top American university at 1995. It is a global leader for IVD (In vitro Diagnostic) products, and unique in China holding GMP, CE, ISO13485 certificates. ACON is also a US FDA registered company of rapid diagnostic and healthcare products. It has been inspected by US FDA and found compliant to cGMP/QSR requirements.
ACON provides a broad range of high quality and competitively priced rapid diagnostic and healthcare products. ACON leads the way in making point of care medical diagnostics more affordable to people all around the world, and the ACON name is well known in over 130 countries.
Product Focus
ACON current product lines include Diabetes Care, Clinical Chemistry including Urinalysis Strips, Urine Analyzer, Dry Chemistry Analyzer, Immunoassay EIA/ELISA and Molecule Biology PCR more than 100 products for the Word Wide Market. ACON products have gained 59 US FDA 510(k) clear letters, 4 SFDA Drug Registration Certificates, 56 SFDA Medical Device Registration Certificates and 88 Products with 188 types CE Certificates. Hundreds of millions of products are produced each year to supply the worldwide distribution network, supplying hospitals, clinical laboratories, physicians' offices, blood banks, home users, and others.
In addition to the ACON brand, we excel in specialized custom design and contract manufacturing and utilize advanced engineering and design techniques to meet the unique specifications of customers in today's global healthcare markets. Our dedication to providing innovative solutions with the highest quality standards ensures that ACON meets its customers' diverse requirement.
Management
ACON Management Team has extensive experience in research and development, quality assurance, regulatory compliance, manufacturing, and marketing for major diagnostic companies. This gives us a unique advantage in understanding the issues and concerns our distributors and partners face in today's healthcare environment, trying to keep costs in line with pricing demands and profitability requirements.
Human resource
Since its inception, ACON well recognize importance of talents to company development. Being devoted become Best Employer with credo of ‘career build talent, talent stimulate career’, ACON decides to continue its strong competitiveness by talent development.
ACON ensures employees capacious space of development including advanced management, performance based promotion, excellent training and competitive salary system.
VISION：Determined to become a world class multinational corporation for global healthcare products and service.
MISSION：ACON is the unique solution for global healthcare.
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岗位职责：
1、负责协助研发新产品开发过程的工作、对技术转移过程进行监控并制定生产过程质量控制点；
2、负责不合格品、不合格物料及生产过程中的异常及时处理；
3、组织相关部门或开展投诉调查，审核或完成投诉报告；
4、物料报废、返工及退回产品的管理；
5、负责对批记录的抽查审核；
6、负责对生产过程质控点进行监控，对质量管理信息数据进行收集与录入，并进行分析；
7、对潜在的质量问题启动纠正预防措施进行改进，协助各部门完成问题的调查、措施的制定以及实施，并对效果进行跟踪确认；
8、负责PQC小组的管理，包括人员的日常管理以及PQC巡检和外观检；
9、审核与产品相关的更改（包括文件）；
10、协助注册完成产品注册的工作以及外审的工作；
11、完成上级临时交办的任务。
任职要求：
1、全日制本科及以上学历,生物、制药、化学相关专业优先；
2、一年以上体外诊断试剂或医疗器械相关行业的质量相关工作经验；
3、能熟练使用英语进行日常交流者尤佳 ；
4、熟练使用办公软件，具备良好的沟通协调能力。
