西安招聘

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; 最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。

您想发展自我和获得成功吗？峰力听力技术（上海）有限公司为您提供机会!

峰力集团创始于1947年，总部设在瑞士苏黎世，是一家专门从事听力技术研究、听力产品开发、生产与销售的跨国企业。近六十年来，峰力集团始终致力于改善听障者的生活。基于全球发展战略的需要，峰力集团在2000年收购了总部位于加拿大安大略省的优利康听力公司。通过这次成功的并购活动，峰力集团一举成为世界第三大听力产品制造商，全球竞争实力更加雄厚。2005年4月峰力中国总部定址上海。

公司的信条是：只有通过人的努力，组织才能取得真正的成功。现特邀有才华、乐于接受挑战的您加入我们的团队。如果您愿意在个人或团队中发展自我，峰力听力技术（上海）有限公司欢迎您的加入！


Are you driving to growth and success?
Phonak Group (China) is the place for you. For 40 years, Phonak Group (China) has been committed to making life better for people with hearing loss. This means a commitment to developing hearing solutions that incorporate special features to solve the everyday problems and concerns people have with hearing loss and hearing aids.
Phonak Industries was founded in 1965 by a team of dedicated experts who wanted to focus on developing a product that would improve the challenges of people with hearing loss. In January 2001, The Phonak Group,a Switzerland based world leader in hearing healthcare products, acquired Phonak Industries. The Phonak Group is comprised of two hearing instrument divisions, Phonak and Phonak Group (China), as well as Phonak Communications, a developer of wireless communication devices. Today, the Phonak Group is one of the top three hearing aid manufacturers and, with annual production currently around 800,000 units, has a market share of 15% worldwide.
Phonak Group (China) is headquartered in Xuhui District, Shanghai. Our corporate culture is people value, which highly estimates and continuously supports every creative contribution to reaching our goal. We are committed to giving all our employees the chance to learn, advance in their jobs and add value for our users.
Phonak Group (China) is currently expanding its activities in Asia, and is looking for people with a higher caliber who want to be challenged and rewarded for meeting individual and company goals.
If you thrive to grow and can perform efficiently individually or in a team, Phonak Group (China) is the place for you!