Product Surveillance Specialist-HC(职位编号:1843219)
通用电气(中国)有限公司 GE China
- 公司规模:500-1000人
- 公司性质:外资(欧美)
- 公司行业:多元化业务集团公司 医疗设备/器械
职位信息
- 发布日期:2013-11-25
- 工作地点:无锡
- 招聘人数:1
- 工作经验:二年以上
- 语言要求:英语熟练
- 职位类别:工程/设备工程师
职位描述
Business Segment
Healthcare Quality
About Us
Role Summary/Purpose
Essential Responsibilities
As a member of complaint handling team, the individual will
- Monitor and drive complaint investigation, review and approve investigation plan, ensure investigation results and conclusion documentation;
- Analyze complaint data for trend identification, organize trending review with cross-functional teams to determine actions for adverse trends;
- Organize and participate in self-check of complaint records to ensure inspection readiness;
- Participate in the hazard evaluation and risk assessment for complaints;
- Assist with the making of action plan and verify its execution;
Key responsibilities include:
Provide support for root cause investigation, action plan making and execution.
Organize trending review with engineering, manufacturing, supplier quality, and service participation to review complaint data and determine actions needed.
Conduct self-audit to ensure the completeness and accuracy of complaint records.
Interface with regulatory affairs leaders and clinical application specialists to assess risk level and identify hazardous/potential hazardous situations.
Provide direction on complaint risk assessment for actual/probable situations.
Support information collection for install base to ensure all complaints are handled in a timely manner.
Provide support for audits, inspections, and management reviews on complaints.
Qualifications/Requirements
MS or higher degrees in engineering with 2+ year experience in quality assurance for regulated electronics, pharmaceutical or medical products industry, OR Bachelor’s degree with minimum of 3 year experience in quality or customer interface functions in medical device, electronics, pharmaceutical industry.
Prior experience using Microsoft Office products (Word, Excel, and PowerPoint).
Fluency in English reading and writing.
Must submit application for employment through gecareers.com or COS if internal to be considered
Desired Characteristics
Experience in service, manufacturing, design or customer issue resolution for medical devices.
Strong process improvement mindset, passion for quality and customer focus. Internal auditor certificate for ISO13485 is a plus.
Excellent verbal English communication skills, strong analytical skills, and the ability to drive cross-functional teams to solve complex problems.
公司介绍
GE公司的历史可追溯到托马斯?爱迪生,他于1878年创立了爱迪生电灯公司。1892年,爱迪生通用电气公司和汤姆森-休斯顿电气公司合并,成立了通用电气公司(GE)。GE是道 琼斯工业指数1896年设立以来唯一至今仍在指数榜上的公司。
2011年GE的年销售达1420亿美元。
GE现有6个产业部门,其中包括:航空、交通运输、医疗、能源、GE金融、家庭和商业解决方案。
GE (NYSE: GE) is Imagination at Work – an advanced global technology, service and finance company that is taking on the world’s toughest challenge. Widely recognized as the world’s largest multi-business company, GE excels in a variety of sectors including energy, oil and gas, water treatment, aviation, healthcare, transportation, lighting, appliances and finance. GE serves customers in more than 100 countries and employs more than 300,000 people worldwide. Jeffrey R. Immelt is Chairman of the Board and Chief Executive Officer of GE.
The company traces its beginnings to Thomas A. Edison, who established Edison Electric Light Company in 1878. In 1892, a merger of Edison General Electric Company and Thomson-Houston Electric Company created General Electric Company. GE is the only company listed in the Dow Jones Industrial Index today that was also included in the original index in 1896.
Total revenue of GE reached $142.0 billion in 2011.
GE is having six businesses including: Aviation, Transportation, Healthcare, Energy, GE Capital, Home and Business Solutions.
联系方式
- 公司网站:http://www.ge.com/
- 公司地址:华佗路1号
- 邮政编码:201103