上海招聘

• Job title: QA Manager

• 职位：QA经理
• Location: Jiading, Shanghai
• 地点：上海嘉定

2. Position in Organization 公司层级

• Report to General Manager
• 汇报给总经理
• Member of management team
• 公司管理团队成员
• Lead and manage the whole quality team, including QC, QA Engineer, lab, etc.
• 领导和管理整个质量团队，包括 QC, QA工程师、实验室等

3. Job Responsibility 工作职责

• Establish, implement and maintain of Quality Management System (QMS) to fully comply with identified standards and regulations, eg. ISO 13485
• 执行、维护公司质量管理体系，以保证完全符合相关法规与标准，如ISO 13485
• Establish, implement raw material qualification and receiving/inspection programs
• 建立、执行合格原材料以及来料检验流程
• Establish, implement in-process QA oversight
• 建立、执行QA过程监控
• Establish, implement product release process
• 建立、执行产品放行流程
• Manage change control to meet requirements of internal and customer requirements
• 管理改变控制流程，确保满足内部和外部客户的要求
• Manage CAPA system to ensure continued monitoring and progress
• 管理纠正预防措施流程，确保持续监控和改进
• Plan and organize management reviews, initiate continuous improvement process
• 组织安排管理层审核，对公司流程进行持续改进
• Organize necessary quality trainings for employees
• 组织安排公司员工进行质量培训
• Responsible for internal and external audit

• 负责公司内部和外部的审核

4. Required Level of Knowledge and Experience 需要的知识和经验

• Bachelor degree or above, engineering major desirable
• 本科或以上，工程专业优先
• More than 3 years of experience in quality management field, Medical device industry desirable
• 3年以上质量管理经验，医疗器械行业优先
• Be familiar with ISO 13485 or IATF 16949requirements
• 熟练掌握ISO 13485或IATF 16949 等法规要求
• Be family with quality tool of problem solving， six sigma GB or BB is preferred.
• 熟练掌握处理质量问题的各种方式方法，6西格玛绿带或黑带优先
• Good team work spirit and communication skills
• 很好的团队合作精神和沟通技巧
• English language fluently spoken and written
• 熟练的英语听说读写能力

5. Salary and Benefits 工资与福利

• Competitive salary package within the industry
• 行业内有竞争力的工资待遇
• Social insurance and housing fund according to government regulation
• 国家规定的五险一金
• Annual leave, marriage leave, maternity leave according to government regulation
• 国家规定的带薪年假、婚假、产假等
• Company outing, birth party, team building activities, etc.
• 公司旅游、生日会、团队建设活动等

6. About Bioanchor 关于佰安氪

Bioanchor Medical Technology (Shanghai) Co., Ltd is a start-up company specialized in the development and manufacturing of biomedical coatings used in implantable medical devices.

Our mission is to provide professional surface treatment technology by combining best-in-class quality and customer service to support the development of medical devices that aid in improving patient outcomes.

佰安氪医疗科技（上海）有限公司是一家年轻的创业公司，专注于研发、生产应用于植入式医疗的生物医学涂层。

我们的使命是向客户提供专业的表面处理技术，通过一流的产品质量和客户服务来支持医疗器械的发展并改善患者的临床效果。

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