职位描述
职位职能:
??体系工程师/审核员??
职位描述:
Purpose of the Job
Be responsible for set up and maintain the Quality Management System (QMS) certification, controlling the pertinent QMS documents and records. Perform Internal audits and coordinate External audits. Responsible in coordinating solutions for Product Quality and other QA activities such as NCR, CAPA.
负责建立和维护质量管理体系认证，管控相关的质量管理体系文件和记录。执行内部审核和协调外部审计。负责为产品质量和其他质量保证行为，例如不合格品报告、纠正与预防措施等协调解决对策。
Tasks & Responsibilities
- Assist QA Manager to draft QMS documentation.
协助QA经理起草质量管理体系文件；
- Daily control and maintain quality system
质量体系的日常维护；
- Ensure the effectiveness implementation of QMS
确保质量管理体系被有效的执行；
- Organize and go through the Internal audit and external audit.
组织并参与内外部质量体系审核；
- Collect quality data, analyze quality issue and follow up handing actions and results.
负责收集统计各项质量数据，分析质量问题，跟踪和评价处理结果；
- Organize conferences related quality issues.
组织质量分析会和质量专题会；
- Be responsible for documents control involving collecting and releasing for all formal documents, such as manufacturing documents, company operation documents, etc.
负责文档的管控，包括收集和公布所有正式文件，例如生产文件、公司运营文件等；
- Performs other duties as required by Manager.
完成上级交付的其他任务。
Basic Education
Bachelor or above, Biology, Pharmacy, Medical Science relevant professional.
生物、医学、制药相关专业本科及以上学历
Work Experience
- At least 3 years working experience in MDD or IVDD quality system.
3年以上医疗器械或体外诊断试剂质量管理体系工作经验
- Be familiar with ISO9001 & ISO13485 Quality System. 熟悉ISO9001& ISO13485质量管理体系
Personal Competencies
- Careful and high responsibility
工作稳重细心，有较强的责任心
- flexibility灵活
- 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
Social Competencies
- Have a good communication skill and coordinate ability
良好的沟通技巧和协调能力
Professional Competencies
Principled/Depth
原则性强/具有的深度的专业知识
Language(s) / Level
Good English communication skill in reading, speaking and writing
良好的英语沟通能力
IT skills
Microsoft Office
熟练使用Microsoft Office软件
企业简介
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!
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