Quality Engineer

Quality Engineer

Smiths Group
5-8 years
Not Specified

Job Description



  • This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site).该求确公符所有适用的法律法规和标准良好的商业惯例和公文件化程(包括所有标准政府业康和环境法规和与现场相关的法规的知识)。
  • Assures that complaint management, including appropriate response to risks, adverse event reporting decisions, and collection and documentation of complaints data.确投诉管,包括适当的风险应对良事件报告决策投诉数的收集和记录。
  • Assures that timely responses regarding product complaints are provided to customers and Regulatory Authorities.确时客户和监管机构馈产投诉。
  • Actively contribute to making better products and bolstering positive relationships with Regulatory Authorities.积为生产更好的产出贡献,并加强与监管机构的积关系。
  • Receive, document, and respond to Smiths Medical product complaints according to global regulatory requirements, and Smith Medical SOPs:根全监管求和密斯医疗标准作程,接收记录并回应密斯医疗产投诉。
  • Process product complaint samples for investigation.处产投诉样进行调查。
  • Maintain complaint records.维护投诉记录。
  • Coordinate internal complaint investigations to ensure completion in a timely manner.调内部投诉调查,确时完。
  • Use judgment to analyze adverse incidents and determine if events must be reported to Regulatory Authorities.使用判断分良事件,并确定是必须监管机构报告事件。
  • Communicate with customers to gain information for complaint investigation and to convey investigation results.与客户沟通,获投诉调查信,传达调查结果。
  • Support site in internal and external audits, as they relate to global product complaints.支公的内部和外部审计,因为它们涉全产投诉。
  • Remain current on Smiths Medical product-related issues and trends.密斯医疗产相关问题和趋势的最新信。
  • Prepare reports and make recommendations regarding adverse complaint trends, the results of complaint investigations, and problem solving activities.就利投诉趋势投诉调查结果和问题解决活动编制报告并出建议。
  • Actively engage in providing input on process improvements.积与供程改进方的
  • Escalate relevant product complaint issues through the appropriate Quality manager, and management, as necessary.必时,通过质和管层上报相关的产投诉问题。
  • Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement.让其他人与促进和与环境康和安全计划,注续改进。
  • Other duties as assigned by supervisor.其他主管布置的任务。

责任与义务
  • Required: Proven experience in quality assurance or quality control in a medical device or similar regulated environment 求:在医疗器械或类似监管环境中的质或质控制方具有验。
  • Required: Proven experience on medical device complaint handling 求:在医疗器械投诉处上具有验。
  • Required: Knowledge of GMP/ GDP requirements and previous database management and analysis experience is required. 求:了解GMP/GDP求,有数管和分验。
  • Knowledge of and expertise in the use of personal computers for spreadsheets (Excel), communication and scheduling (Outlook), word processing (Word), and various databases (Oracle, SharePoint) 个人计算机在电表格(Excel)沟通和计划(Outlook)文字处(word)和数库(OracleSharePoint)中的使用知识和专业技能。
  • Accurate and professional verbal and written communication and presentation skills and written English is required. 准确和专业的头和书沟通和表达能力和书英语是必需的。
  • Ability to understand regulatory requirements and how they impact Company response to customers. 能够解法规求其如何影公对客户的应。
  • Ability to understand and gather the information necessary to troubleshoot technical problems with medical products. 能够解并收集解决医疗产技术问题所需的信。

多元性和包容性
我们相信的视角和背景是公蓬勃展的关键。所有符件的申请人,论肤色宗教性别性性别认国济状况残疾年龄或任何其他法律护的情形,都将获得平等的就业机会。我们为自己是一家具有包容性的公而感到自豪,我们的价值观建立于平等和规的基础上,我们赞扬支和欢迎多样性的业文化。
个人履历
University Degree (BA degree) and major in electronics preferred大学本科学历电专业优先考虑。
Medical device work experience, above 5 years and powered medical device preferred.医疗行业从业历,5年以上以有设备历优先考虑。
Prefer at least 3 year experience working with product complaints in a medical device company with medical claims or equivalent有3年以上医疗器械公产投诉处验或等验者优
关于密斯
在密斯,我们用尖端技术,设计 制造和供市场领先的解决 方案,断满足客户越越 高的需求。我们的产和务天都与数百万人的生活 产生密切的系。我们是英国富时100指数的公,全业务覆盖约23,000员工,分布在55个国家。我们的产和务对客户的往往至关, 时,公的尖端技术和高水平务也有助于客户竞争优势。我们的解决方案对世界产生了 的影 -推动工业展改善医疗系统增强安水平推动互连互通,共建新家园。我们的产和务通常对客户的说是至关的,而我们所专有的技术和高水平的务有助于创造竞争优势。我们欢迎具有探索精神敢于承担责任于接挑战的事,加入密斯,和我们在这个拥有近170年创新历以拥有五个全事业部个领域专家的业一起工作。(密斯集团中国官网:www.smithsgroup.cn)
关于密斯医疗
密斯医疗公一直在寻找具有积影世界地人民的康和祉的热情的人。如果你有好奇心,喜欢挑战,并想有所作为,那就把你的带到这里,你的机会将会是无的。我们为自己在160年的创新历中一直在推动人类世界进而感到自豪。我们凭借从的角度看问题适应而且从滞。通过断的考,推出了一些在医疗领域最值得信赖的牌。今天,我们是一个由8000事组的秒钟就以触动7个人生命的全业务中心。因此,无论您是一验丰富的专业人士,还是刚刚开始您的业生涯,我们的全规模以注展都味以为适的事供佳的业机会。现在就是一个加入密斯的最佳时机。帮助我们创造未。

About Smiths Group

Job Source : www.smiths.com

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