Smiths Medical Job - 40390849 | CareerArc
  Search for More Jobs
Get alerts for jobs like this Get jobs like this tweeted to you
Company: Smiths Medical
Location: Hangzhou, Zhejiang, China
Career Level: Mid-Senior Level
Industries: Healthcare, Pharmaceutical, Biotech

Description

Duties & Responsibilities

  • 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).

该职位要求确保公司运营符合所有适用的法律、法规和标准、良好的商业惯例和公司文件化程序(包括所有标准、政府职业健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.

确保投诉管理,包括适当的风险应对、不良事件报告决策、投诉数据的收集和记录。

  • Assures that timely responses regarding product complaints are provided to customers and Regulatory Authorities.

确保及时向客户和监管机构反馈产品投诉。

  • Actively contribute to making better products and bolstering positive relationships with Regulatory Authorities.

积极为生产更好的产品做出贡献,并加强与监管机构的积极关系。

  • Receive, document, and respond to Smiths Medical product complaints according to global regulatory requirements, and Smith Medical SOPs:

根据全球监管要求和史密斯医疗标准操作程序,接收、记录并回应史密斯医疗产品投诉。

  • Process product complaint samples for investigation.

处理产品投诉样品进行调查。

 

  • Maintain complaint records.

维护投诉记录。

  • Coordinate internal complaint investigations to ensure completion in a timely manner.

协调内部投诉调查,确保及时完成。

  • Use judgment to analyze adverse incidents and determine if events must be reported to Regulatory Authorities.

使用判断分析不良事件,并确定是否必须向监管机构报告事件。

  • Communicate with customers to gain information for complaint investigation and to convey investigation results.

与客户沟通,获取投诉调查信息,传达调查结果。

  • Support site in internal and external audits, as they relate to global product complaints.

支持公司的内部和外部审计,因为它们涉及全球产品投诉。

 

  • Remain current on Smiths Medical product-related issues and trends.

保持史密斯医疗产品相关问题和趋势的最新信息。

  • Prepare reports and make recommendations regarding adverse complaint trends, the results of complaint investigations, and problem solving activities.

就不利投诉趋势、投诉调查结果和问题解决活动编制报告并提出建议。

  • Actively engage in providing input on process improvements.

积极参与提供流程改进方面的意见

  • Escalate relevant product complaint issues through the appropriate Quality manager, and management, as necessary.

必要时,通过质量经理和管理层上报相关的产品投诉问题。

 

  • Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement.

让其他人参与、促进和参与环境、健康和安全计划,注重持续改进。

 

  • Other duties as assigned by supervisor.

其他主管布置的任务。

Diversity & Inclusion

We believe that different perspectives and backgrounds are what make a company flourish. All qualified applicants will receive equal consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, economic status, disability, age, or any other legally protected characteristics. We are proud to be an inclusive company with values grounded in equality and ethics, where we celebrate, support, and embrace diversity.

The Individual

Education and Experience

 

l  University Degree (BA degree) and major in electronics preferred

大学本科学历、电子专业优先考虑。

l  Medical device work experience, above 5 years and powered medical device preferred.

医疗行业从业经历,5年以上以及有源设备经历优先考虑。

l  Prefer at least 3 year experience working with product complaints in a medical device company with medical claims or equivalent

有3年以上医疗器械公司产品投诉处理经验或同等经验者优先。

 

Technical Knowledge and Skills

 

l  Required: Proven experience in quality assurance or quality control in a medical device or similar regulated environment.

要求:在医疗器械或类似监管环境中的质量保证或质量控制方面具有经验。

l  Required: Proven experience on medical device complaint handling

要求:在医疗器械投诉处理上具有经验。

l  Required: Knowledge of GMP/ GDP requirements and previous database management and analysis experience is required.

要求:了解GMP/GDP要求,有数据管理和分析经验。

l  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)

个人计算机在电子表格(Excel)、沟通和计划(Outlook)、文字处理(word)和各种数据库(Oracle、SharePoint)中的使用知识和专业技能。

 

Abilities

 

l  Accurate and professional verbal and written communication and presentation skills and written English is required.

准确和专业的口头和书面沟通和表达能力和书面英语是必需的。

l  Ability to understand regulatory requirements and how they impact Company response to customers.

能够理解法规要求及其如何影响公司对客户的反应。

l  Ability to understand and gather the information necessary to troubleshoot technical problems with medical products.

能够理解并收集解决医疗产品技术问题所需的信息。

l  Ability to work independently with minimal supervision.

能够在最小的监督下独立工作。

 

Planning and Decision Making

 

l  Self schedule day to day planning.

能自己计划安排日常工作。

l  Able to think quickly and use initiative in resolution of customer complaints.

能够快速思考并主动解决客户投诉。

l  Reactive to directives from supervisor.

 

对主管的指示作出反应。

 

About Smiths

At Smiths we apply leading-edge technology to design, manufacture and deliver market-leading innovative solutions that meet our customers' evolving needs, and touch the lives of millions of people every day. We are a FTSE100, global business of around 23,000 colleagues, based in 55 countries. Our solutions have a real impact on lives across the planet, enabling industry, improving healthcare, enhancing security, advancing connectivity and supporting new homes. Our products and services are often critical to our customers' operations, while our proprietary technology and high service levels help create competitive advantage. We welcome colleagues with a curious mind, who are happy with responsibility, enjoy a challenge and are attracted by the idea of working at a business with an almost 170 year history of innovation, and five global divisions, all experts in their field. 

About Smiths Medical

Smiths Medical is always looking for people with a passion to positively impact the health and wellbeing of people around the world. If you have a curious mind, relish a challenge and want to make a difference then bring your talents here and your opportunities are endless. We're proud that we've been helping propel the human world forwards during our 160-year history of innovation. By looking at things differently. By adapting and never standing still. And by always thinking big we have introduced some of the most trusted brand names in healthcare. Today we're an aligned global business 8,000 colleagues, that touches the lives of 7 people every second across the globe. So whether you're an experienced professional or just starting out on your career, our global scale and focus on growth means great career opportunities for the right colleagues. There's never been a better time to join Smiths. And help us create the future.


 Apply on company website