大庆招聘

Business Segment
Healthcare Quality

About Us
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Role Summary/Purpose
The Product Surveillance Engineer is responsible for providing manufacturing and/or engineering process support in accordance with documented procedures and practices. The Product Surveillance Engineer is responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local business.

Essential Responsibilities
• Key contributor as part of a complaint handling unit
• Developing and implementing methods and procedures for effective trending of complaints
• Facilitating complaint investigation
• Engaging product design owners to determine effective CAPA
• Identifying complaints that represent further evaluation under 21CFR Part 803 (MDR)
• Reviewing appropriate criteria for closure of complaints
• Owning and communicating metrics on status
• Continuously working to improve the process

Quality Specific Goals:
1. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
2. Complete all planned Quality & Compliance training within the defined deadlines
3. Identify and report any quality or compliance concerns and take immediate corrective action as required
4. Identify and report any compliance gaps related to the full Quality System Regulation (QSR) and Current Good Manufacturing Practices (CGMP) requirements
5. Ensure zero repeat findings from previous internal and external audits within area of responsibility.
6. Timely complaint handling and reporting
7. Provide objective evidence of complaint handling process through compliant documentation

Qualifications/Requirements
1. Bachelor’s degree in Engineering; or high school diploma/GED and minimum 2 years work experience in Quality or Regulatory Assurance related field
2. Minimum 2 years work experience in biomedical, electrical, mechanical or software product development and design

Desired Characteristics

1. Product-specific knowledge
2. Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes
3. Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production &process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc.
4. Demonstrated knowledge of 21CFR Part 820
5. Ability to demonstrate GEHC Growth Values
6. Demonstrated experience prioritizing conflicting demands in an extremely fast paced environment
7. Ability to work independently & in a team setting
8. Excellent verbal, written, and presentation skills with the ability to communicate business issues clearly in English (and where appropriate, be able to communicate in the local language verbally and in writing).
9. Excellent interpersonal, organizational, and influencing skills
10. Familiarity with the application of medical device as it relates to patient safety
11. Ability to analyze and process data, and draw the appropriate conclusions
12. Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems
13. Ability to analyze and process data, and draw the appropriate conclusions
14. Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems
15. Prior experience working with Microsoft Office products
16. Working knowledge of GEHC products

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.