广州招聘

职位描述：
1.对体系问题跟踪解决，协助责任部门采取纠正预防措施，并验证，评价改进效果；
2.根据公司实际情况梳理体系流程，组织完善相关文件和制度；
3.负责体系文件的审核，对公司体系文件的总体完整性和系统性进行评价和改进；
4.制定年度内审计划和内审实施计划，组织内审员对质量管理体系开展内审，编制内审报告；
5.开展员工质量意识培训策划，负责开展全体员工质量体系意识和知识培训，新法规宣贯；
6.协助开展外审，管理评审；
7.配合对公司供方质量体系情况进行评审，包括现场审核。

职位要求：
1.本科及以上学历，理工科或质量管理等相关专业；
2.熟知GMP标准要求，ISO13485质量管理体系标准；
3.了解ISO9001体系知识，产品目标国家和地区法规要求（CE、FDA）；
4.具备目标管理，培训师技巧，具有良好的沟通协调及组织策划能力；
5.有质量管理体系内审员证书，熟悉外审标准和流程；
6.5年以上QC、QA工作经验，有医疗器械（医药）企业从业经验者优先。

    瑞奇外科成立于2005年, 是美国Reach Surgical, Inc. 在华投资的外商独资企业, 是集研发、生产、销售于一体的专业化的外科医疗器械及医疗设备提供商。
    瑞奇外科的产品技术立足高端产品平台, 其全线产品均已获得欧盟CE认证, 且RCS 系列端吻合器已经取得美国FDA的产品认证。目前公司在美国Cincinnati, 北京和上海设有三个研发中心, 致力于为全球的临床外科医生提供先进的和高质量的微创外科解决方案。
    瑞奇外科拥有一支专业化的市场销售团队, 恪守“关爱生命、创新不止”的信条， 以高品质的产品服务于全球的临床医生和患者。
    
    公司地址：天津经济技术开发区第四大街5号B座四层（泰达医药研发大厦）——瑞奇外科（总部）
              上海浦东新区郭守敬路——华外医疗（上海）
              
    公司网址：http://www.reachsurgical.com/
    
    注：八小时工作制，周末休息
       
        
     Reach？ Surgical (Beijing), Inc., established in 2005, is a wholly owned foreign enterprise invested by Reach？ Surgical, Inc., a USA medical device company. It is dedicated to providing advanced medical devices and surgical equipments through its global product development centers, manufacturing facility and distribution network in China.
    Quality matters as we treasure life. Reach Surgical (Beijing), Inc. follows US c-GMP. All our products have CE approvals and RCS series circular staplers have obtained the FDA approval. Reach Surgical (Beijing), Inc. has three advanced R&D centers in Cincinnati, Ohio, Beijing, and Shanghai. We are dedicated to providing the advanced and best solution of minimally invasive surgery for clinical surgeons.
    “Innovating for life” is what we believe in. With a professional marketing and sales teams, Reach Surgical (Beijing), Inc. is devoting to providing our customers products and services of the highest quality.
China Surgical Corporation (Shanghai) is a solely foreign-owned enterprises, a new subsidiary invested by China Surgical (Cayman)Corporation in China.
    China Surgical （ Cayman ）Corporation commits itself in developing, manufacturing and selling advanced surgical operational staplers, and it has three serials of products:
1.    Open automatic Staplers
2.    Endoscopic automatic Staplers
3.    Ultrasonic knife operation system
     China Surgical Corporation has invested and found Reach Surgical (Beijing) Co., in 2005, thereafter invested and found China Surgical Corporation (Shanghai) in 2007 which is researching, developing and manufacturing micro-port surgical operation instruments.
     The core of this company is made up of technical and management experts who have worked many years in American top surgical companies with advanced surgical technology and achievement, and this company cooperate with Peking Union Medical College and Beihang University actively, then build a new road to research, study and develop in the surgical field.
    It has class 100000 cleaning room, various manufacturing equipments, perfect machining means and validating means. Its employees are returnees who receive their education abroad and Chinese professional people, and more than 80% of them are bachelors or above.
    Guided by the faith “Innovation for life”, this company serves Chinese patients by high-quality products, and provides a serial of advanced solutions for Chinese medical organizations in the micro-port surgical field.