招聘人数：1-2人
到岗时间：不限
年龄要求：不限
婚况要求：婚姻状况
语言要求：
英语
Responsibilities:
- Ensure Quality Management System (QMS) is effectively established, implemented and maintained to be in compliance with ISO13485 / ISO9001 / Chinese Central and Local FDA Regulations and align with Phonak Quality System. 确保ISO13485 / ISO9001质量管理体系的建立、执行和维护，符合国家和地方药监管理法规，并和总部的质量管理体系保持一致；
- Be the Management Representative, responsible for internal and external audit. Provide regulatory consultant, identify and monitor compliance of business operation.作为管理者代表，负责内部和外部的审核；提供法规咨询提案，识别并维持业务运行的合规性。
- Cooperate with Product Register department, prepare and submit QMS documents for product register. 准备并提交新产品质量体系文件，协调产品注册；
- Manage adverse event according to FDA regulation.按照药监局的要求，处理不良事件；
- Manage customer complaint, cooperate with related department take CAPA plan and implementing.管理客户投诉问题，协调相关部门制定纠正预防措施并落实。
- Responsible for CQC (Customer Quality Communication) system, continue improve customer quality satisfaction.负责客户质量沟通系统，持续提高客户质量满意度。
- Establish and optimize Visual Quality (VQ) system on two levels of front line and operation level to quick response for quality issues.在运营和一线两个层面，建立优化质量目视化系统，快速响应各类质量问题。
- Apply quality tools, especially 6 sigma tools, to collection and analysis quality data, take effective actions, continue improving product quality.应用各类质量工具，尤其是6西格玛工具，收集并分析质量数据，采取有效措施，持续提高产品质量。
- Interfaces with suppliers when required to resolve issues pertaining to product Quality. 与供应商协调相关的原料质量问题；
- Manage QC, QMS, CQC team. Oversees work efficiency / assignments of subordinates, ensures adherence to deadlines and objectives.管理QC, QMS, CQC团队，监督下属工作效率和任务目标的实现；
- Selects, appraises, coach and disciplines staff in accordance with corporate policies and procedures. 根据公司政策和程序选择、评估、培训和考核部门员工；
- Performs other duties as required by Manager. 完成上级交付的其他任务。
Qualifications:
- Bachelor’s degree or above, major in electronic or biomedical engineering or quality management.本科及以上学历，电子或生物医学工程或质量管理相关专业；
- Familiar with ISO9001 and 13485 of medical device manufacturing environment熟悉ISO9001和13485医疗器械产品生产管理体系和标准；
- Strong background in electronic product quality management at a supervisory level. 很强的电子行业质量管理经验；
- Background in Hearing aid manufacturing at a supervisory level is preferred; *好有助听器生产行业管理经验；
- Previous Hands On experience in an ISO 9001& 13485 medical manufacturing environment. ISO9001 and 13485医疗产品生产管理体系和标准的实际起草或推动经验；
- Proactive and result and objective orientation.积极思维并以结果和目标为导向；
- Creativity and ability to change有创造性，并且善于根据岗位要求及时调整自己；
- Ability to work under pressure，stress resistance. 能在压力下工作，具有一定的压力调节能力；
- Good communication skill in different environment of customer, supplier and government administrator.在客户、供应商、政府部门等不同的环境下，具备良好的沟通能力；
- Good team player in corporation. 具有良好的合作精神和方法；
- Skilled teambuilding practices很强的团队创建能力；
- Recognizing the personalities of team members对团队中的成员能正确评价；
- Encourage, promote, challenges and develops employees competency. 鼓励、推动、挑战、提高团队成员的能力发展；
- 6 sigma knowledge, GB level or above.6西格玛知识，绿带或以上；
- Ability of Knowledge refreshing and updating强烈的知识更新和学习的能力；
- Mandarin (native speaker) 中文（普通话流利）；
- English : excellent英文（具有较强的听说读写能力）；
- Microsoft Office, Proficient PPT and Excel skill.熟练使用Microsoft Office尤其是PPT和Excel软件。
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