Business GE Technology InfrastructureBusiness Segment Technology Infrastructure - HealthcareAbout UsGE Healthcare provides transformational medical technologies that are shaping a new age of patient care. GE Healthcare’s expertise in medical imaging and information technologies, medical diagnostics, patient monitoring and life support systems, disease research, drug discovery, and biopharmaceutical manufacturing technologies is helping physicians detect disease earlier and to tailor personalized treatments for patients. GE Healthcare offers a broad range of products and services that are improving productivity in healthcare and enhancing patient care by enabling healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases, and other conditions. Headquartered in the United Kingdom, GE Healthcare is a $17 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 43,000 people committed to serving healthcare professionals and their patients in more than 100 countries. GE is an equal opportunity employer.Role Summary/PurposeThe QA Leader will manage quality systems, processes, and procedures to assure product safety and quality by driving business alignment to correct industry requirements and business objectives by managing quality system design, controls, and continuous improvementEssential Responsibilities· Accountable for assisting the Quality Assurance Site Manager to ensure/follow up/implement corrective actions that are raised by deviations, internal audit or regulatory inspection· Responsible for managing quality systems, processes and procedures to assure product quality and safety· Responsible for engaging strong intradepartmental and cross-functional/organizational relationships to drive Quality System Requirements (QSRs)· Owning the development and maintenance of policies and procedures for departmental functions· Providing leadership and facilitates problem resolution, resource utilization, career counseling, coaching and mentoring of team members· Influencing site compliance to Quality policy, Quality Management System procedures, and Quality Star guidelines· Influencing participation in compliance to internal and external regulations· Influencing quality system metrics such as Corrective and Preventive Action, training metrics, completion and complaint resolution metrics· Provide guidance to product development teams as to the required deliverables to ensure compliance throughout product development cycle.· Review, assess and approve product design milestones and deliverables throughout product development cycle to ensure compliance.· Assist engineering/operational quality/compliance representatives to identify compliance risks during the product development cycle.Qualifications/Requirements1. Bachelor’s degree (or high school diploma/GED plus 4 years experience work experience)2. 3 years experience working in a regulated medical device or pharmaceutical environment, quality engineering, quality control/assurance, or regulatory assurance3. Ability to effectively communicate using ChineseAdditional Eligibility QualificationsDesired Characteristics1. Demonstrated experience in the medical device or pharmaceutical industry and knowledge of quality system regulations and policies2. Demonstrated ability to develop & lead process implementation & improvement in a team environment3. Experience with some or all of the following:Ø Design controls, design verification and validation activitiesØ Production and process controlsØ CAPA, complaints and risk managementØ Understanding of product quality improvement using tools such as Six Sigma, DFRØ Experience performing internal audits4. Demonstrated effective interpersonal and networking skills5. Prior experience using word processing, spreadsheet, and presentation software6. Demonstrated ability to successfully comprehend & carry out/execute actions7. Effective oral and written communication skills8. Analytical & problem-solving skills/root-cause analysis9. Exceptional conflict-resolution skills10. Ability to interface with top organizational leadership and internal and external customers, responding in a professional manner11. Ability to prioritize and drive multiple programs12. Integrity: Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions, and when dealing with others13. Accepting constructive criticism and dealing calmly and effectively with high-stress situations. This includes continuing to persevere and remaining calm in challenging or frustrating circumstances14. External Focus: Understanding customer needs, marketplace dynamics, industry trends, and the competitive landscape in the industry/function and considering the external impact of business activities and decisions on the external environment15. Inclusiveness: Energizing others by building a connection with the team through personal involvement and trust and providing feedback and coaching to help develop others16. Clear thinker: Simplifying strategy into specific actions with clear accountability, making decisions with speed and accuracy based on best available information, and communicating priorities clearly and concisely
About GE GE (NYSE: GE) is Imagination at Work -- a diversified global infrastructure, finance and media company that is built to meet essential world needs. From energy, water, transportation and health to access to money and information, 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 $183 billion in 2008.GE is having five businesses including two infrastructure segments: GE Technology Infrastructure, GE Energy Infrastructure, GE Capital, NBC Universal and GE Consumer & Industrial.GE in ChinaGE started doing business in China as early as 1906 and was considered one of the most active foreign companies in the country at the time. In 1908, the first GE light plant was built in Shenyang. GE acquired Anderson, Meyer & Co. in 1934 and started to provide installation and repair services of imported electric equipment in China. GE resumed trade with People’s Republic of China in 1979. It opened GE Hangwei Medical Systems Co., Ltd in Beijing, which is its first joint venture in China in 1991. All of GE’s industrial businesses have set up operations and established over 50 legal entities in China with more than 12,000 employees. Its financial services sector is also seeking business opportunities as WTO opened China market. The sales revenue of GE in China is $4.64 billion in 2008. Besides business commitments, GE continues to act as a responsible corporate citizen in China. In 2008 alone, over 3,200 GE Volunteers in Greater China had led over 190 community projects, contributing over 22,000 volunteer hours, servicing communities in 18 different locations across Greater China (Beijing, Changzhou, Chongqing, Deyang, Guangzhou, Hangzhou, Hong Kong, Taiwan, Mianzhu, Nanjing, Qinhuangdao, Shanghai, Shenyang, Shenzhen, Suzhou, Tianjin, Wuhan, Wuxi), focusing on education, healthcare, elderly care, environment, and human services.
