北京招聘

Business Segment
Healthcare Quality

About Us
X

Role Summary/Purpose

Essential Responsibilities
• Provide support to routine activities, projects, development and training relevant to area of expertise.
• Support the development and maintenance of Quality System metrics
• Supporting the preparation and execution of Quality Management Reviews at the site and P&L &GEHC levels. Assess regulatory impact on product and manufacturing processes. This may include acting as quality expert and approval/authorisation of regulatory specifications and submissions.
• Analyze & communicate proposed, new or changing requirements
• Providing system support to site in relation to key Electronic Management Systems.
• Maintain & keep quality procedures up to date and reflective of regulatory requirements.
• Assist in validation activities in relation to equipment, processes and/or computer systems.
• Represent QA on development projects and advise on the adequacy of validation of facilities, equipment and new products/processes, including designing strategies to ensure adequate data is gathered.

Qualifications/Requirements
1. B.S. Degree in business or technical field or equivalent relative experience to area of specialization.2. 2-year experience in a medical device or pharmaceutical industry. 3. 2-year experience with CA/PA systems, including complaint handling.4. 2-year experience applying regulations (including FDA, cGxP).5. Proficient with relevant MS Office applications.6. Ability to identify root cause of problem and creatively problem solve to gain resolution.7. Ability to communicate effectively in English (both written and oral).8. Ability to work independently in fast-paced environment with little supervision.9. Ability to adapt to constant change and influence positive change effectively.10. Team-oriented and responsive to customer needs.11. Quality-Focused, Attentive to Detail and Results-Oriented.

Desired Characteristics
1. Statistics education and or training2. Experience developing and tracking quality metrics3. Knowledge of Quality Systems policies and regulations (ISO, GxP, FDA, and other key regulatory bodies) and background in pharmaceutical Quality Assurance & processes4. Analytical/problem solving/root-cause analysis skills5. Familiar with Continuous Improvement methodologies, including Six Sigma

通用电气（GE) 公司是一家全球领先的科技、服务和金融公司，是全球最大的多元化企业，致力于解决世界上最棘手的问题。GE的产品和服务范围广阔，从能源、石油天然气、水处理、航空、医疗、运输系统、家电、照明，到金融，客户遍及全球100多个国家，拥有30多万员工。杰夫?伊梅尔特先生是现任董事长及首席执行官。

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.