大庆招聘

Business Segment
Healthcare Quality

About Us
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Role Summary/Purpose
A Quality Assurance and Regulatory Affairs Director is responsible for driving the vision, strategy, management and evolution of the Quality Management System (QMS).

Essential Responsibilities
• Forming a sustainable quality culture based on compliance to regulations, patient safety, and continuous improvement of quality processes to benefit the end customer. • Partnering with the business leadership team to drive wing-to-wing product quality through critical metrics trend analysis and implementation of improvement initiatives for the total product life cycle. • Acting as the interface between the P&L and the Core QA/RA function, implementing central programs in an appropriate compliant manner within the P&L. • Driving training, enhancement, and adoption of the QMS framework and tools. • Providing effective guidance and oversight for quality processes, as well as owning key decisions for the total product life cycle. • Ensuring compliance to existing and applicable global Quality Systems Requirements. • Translating new industry trends and requirements into business policies and practices. • Managing internal and external audits across the business sites to ensure compliance as required by the business and regulatory agencies. • Staffing and managing a globally disperse team of QA/RA professionals with the required skills. and experience to execute their job responsibilities. 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. Lead the execution of regulatory approvals for products in the applicable target markets. 5. Ensure new product introductions and installed-base activities comply with existing and applicable regulations globally. 6. Complete all management reviews in accordance with management controls procedures. 7. Ensure on-time reporting of adverse events globally. 8. Drive timely closure of customer complaints, field actions, and quality system non-conformances. in partnership with functional teams.

Qualifications/Requirements
1. Bachelor’s degree in Engineering or Scientific discipline or High School diploma/GED and a minimum of 10 years Quality Management experience in the medical device or pharmaceutical industry2. Minimum 7 years working in a Quality Management role in a regulated industry and experience interfacing with the FDA/CFDA3. Minimum of 5 years supervisory experience (i.e. managing direct reports), including hiring, training, coaching and performance management activities4. Strong knowledge of quality systems, including but not limited to ISO, GxP, FDA5. Willingness to travel globally 20% of the time6. Ability to communicate in English

Desired Characteristics
1. Demonstrated experience working in a cross-functional environment and proven ability to influence and build consensus among multiple functions including engineering, operations, regulatory affairs and medical affairs1. Ability to work independently in fast-paced environment with little supervision.2. Experience building a Quality Management System from the ground up3. Professional certification in Quality Assurance or Regulatory Affairs4. Strong written and oral communications at all levels of the organization5. Demonstrated ability to work across multiple functions and build consensus6. Six Sigma training and/or certification

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.