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(fù)責(zé)建立和維護(hù)質(zhì)量管理體系認(rèn)證，管控相關(guān)的質(zhì)量管理體系文件和記錄。執(zhí)行內(nèi)部審核和協(xié)調(diào)外部審計(jì)。負(fù)責(zé)為產(chǎn)品質(zhì)量和其他質(zhì)量保證行為，例如不合格品報(bào)告、糾正與預(yù)防措施等協(xié)調(diào)解決對(duì)策。
Tasks & Responsibilities
- Assist QA Manager to draft QMS documentation.
協(xié)助QA經(jīng)理起草質(zhì)量管理體系文件；
- Daily control and maintain quality system
質(zhì)量體系的日常維護(hù)；
- Ensure the effectiveness implementation of QMS
確保質(zhì)量管理體系被有效的執(zhí)行；
- Organize and go through the Internal audit and external audit.
組織并參與內(nèi)外部質(zhì)量體系審核；
- Collect quality data, analyze quality issue and follow up handing actions and results.
負(fù)責(zé)收集統(tǒng)計(jì)各項(xiàng)質(zhì)量數(shù)據(jù)，分析質(zhì)量問題，跟蹤和評(píng)價(jià)處理結(jié)果；
- Organize conferences related quality issues.
組織質(zhì)量分析會(huì)和質(zhì)量專題會(huì)；
- Be responsible for documents control involving collecting and releasing for all formal documents, such as manufacturing documents, company operation documents, etc.
負(fù)責(zé)文檔的管控，包括收集和公布所有正式文件，例如生產(chǎn)文件、公司運(yùn)營文件等；
- Performs other duties as required by Manager.
完成上級(jí)交付的其他任務(wù)。
Basic Education
Bachelor or above, Biology, Pharmacy, Medical Science relevant professional.
生物、醫(yī)學(xué)、制藥相關(guān)專業(yè)本科及以上學(xué)歷
Work Experience
- At least 3 years working experience in MDD or IVDD quality system.
3年以上醫(yī)療器械或體外診斷試劑質(zhì)量管理體系工作經(jīng)驗(yàn)
- Be familiar with ISO9001 & ISO13485 Quality System. 熟悉ISO9001& ISO13485質(zhì)量管理體系
Personal Competencies
- Careful and high responsibility
工作穩(wěn)重細(xì)心，有較強(qiáng)的責(zé)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(diào)節(jié)能力
Social Competencies
- Have a good communication skill and coordinate ability
良好的溝通技巧和協(xié)調(diào)能力
Professional Competencies
Principled/Depth
原則性強(qiáng)/具有的深度的專業(yè)知識(shí)
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(yè)簡介
您想發(fā)展自我和獲得成功嗎？峰力聽力技術(shù)（上海）有限公司為您提供機(jī)會(huì)!
峰力集團(tuán)創(chuàng)始于1947年，總部設(shè)在瑞士蘇黎世，是一家專門從事聽力技術(shù)研究、聽力產(chǎn)品開發(fā)、生產(chǎn)與銷售的跨國企業(yè)。近六十年來，峰力集團(tuán)始終致力于改善聽障者的生活。基于全球發(fā)展戰(zhàn)略的需要，峰力集團(tuán)在2000年收購了總部位于加拿大安大略省的優(yōu)利康聽力公司。通過這次成功的并購活動(dòng)，峰力集團(tuán)一舉成為世界第三大聽力產(chǎn)品制造商，全球競爭實(shí)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。現(xiàn)特邀有才華、樂于接受挑戰(zhàn)的您加入我們的團(tuán)隊(duì)。如果您愿意在個(gè)人或團(tuán)隊(duì)中發(fā)展自我，峰力聽力技術(shù)（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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