職位描述
職位職能:
??體系工程師/審核員??
職位描述:
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.
負責建立和維護質量管理體系認證，管控相關的質量管理體系文件和記錄。執行內部審核和協調外部審計。負責為產品質量和其他質量保證行為，例如不合格品報告、糾正與預防措施等協調解決對策。
Tasks & Responsibilities
- Assist QA Manager to draft QMS documentation.
協助QA經理起草質量管理體系文件；
- Daily control and maintain quality system
質量體系的日常維護；
- Ensure the effectiveness implementation of QMS
確保質量管理體系被有效的執行；
- Organize and go through the Internal audit and external audit.
組織并參與內外部質量體系審核；
- Collect quality data, analyze quality issue and follow up handing actions and results.
負責收集統計各項質量數據，分析質量問題，跟蹤和評價處理結果；
- Organize conferences related quality issues.
組織質量分析會和質量專題會；
- Be responsible for documents control involving collecting and releasing for all formal documents, such as manufacturing documents, company operation documents, etc.
負責文檔的管控，包括收集和公布所有正式文件，例如生產文件、公司運營文件等；
- Performs other duties as required by Manager.
完成上級交付的其他任務。
Basic Education
Bachelor or above, Biology, Pharmacy, Medical Science relevant professional.
生物、醫學、制藥相關專業本科及以上學歷
Work Experience
- At least 3 years working experience in MDD or IVDD quality system.
3年以上醫療器械或體外診斷試劑質量管理體系工作經驗
- Be familiar with ISO9001 & ISO13485 Quality System. 熟悉ISO9001& ISO13485質量管理體系
Personal Competencies
- Careful and high responsibility
工作穩重細心，有較強的責任心
- flexibility靈活
- Ability to work under pressure，stress resistance
能在壓力下工作，具有一定的壓力調節能力
Social Competencies
- Have a good communication skill and coordinate ability
良好的溝通技巧和協調能力
Professional Competencies
Principled/Depth
原則性強/具有的深度的專業知識
Language(s) / Level
Good English communication skill in reading, speaking and writing
良好的英語溝通能力
IT skills
Microsoft Office
熟練使用Microsoft Office軟件
企業簡介
您想發展自我和獲得成功嗎？峰力聽力技術（上海）有限公司為您提供機會!
峰力集團創始于1947年，總部設在瑞士蘇黎世，是一家專門從事聽力技術研究、聽力產品開發、生產與銷售的跨國企業。近六十年來，峰力集團始終致力于改善聽障者的生活?；谌虬l展戰略的需要，峰力集團在2000年收購了總部位于加拿大安大略省的優利康聽力公司。通過這次成功的并購活動，峰力集團一舉成為世界第三大聽力產品制造商，全球競爭實力更加雄厚。2005年4月峰力中國總部定址上海。
公司的信條是：只有通過人的努力，組織才能取得真正的成功?，F特邀有才華、樂于接受挑戰的您加入我們的團隊。如果您愿意在個人或團隊中發展自我，峰力聽力技術（上海）有限公司歡迎您的加入！
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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