天津招聘

Business Segment

Healthcare Quality

About Us

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Role Summary/Purpose

A Quality and Regulatory Assurance Leader ensures CAPAs and AdPromo for China Mainland and process compliance to China regulatory requirements. Support QARA Director to lead China Region CAPA Review Board to review and provide oversight of NC, investigations, root causes, recommended corrective and preventative actions, effectiveness checks and CAPA related metrics.

Essential Responsibilities

•Fully accountable lead to gain and maintain the certificate of AdPromo approved by CFDA, Shanghai FDA. •Fully accountable to lead RA and to work closely with Central Marketing, Legal, Modalities and Service to review and approve AdPromo, and ensure compliance to applicable regulations. •Leading and supporting continuous improvement activities on CAPA and AdPromo compliance and metrics development/implementation. •Participating in the development and maintenance of quality systems, processes and procedures to assure CAPAs and AdPromo compliance. •Support QARA Director to lead the operation mechanism of China Region CAPA Review Board. •Assisting the QARA Director in preparation for internal/external audits and implementation of corrective actions to address non-conformities on AdPromo. •Coaching and mentoring functional teams on the development, maintenance and simplification of local procedures regarding CAPA and AdPromo. •Supporting development and maintenance of product approval/clearance/licensing documentation and notifications as required by global regulatory agencies. 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 AdPromo review and approval, gain certificate within the defined deadlines. 3.Lead China Region CAPA Review Board to maintain ZERO late CAPAs of AdPromo NCs within the defined deadlines. 4.Complete all planned Quality & Compliance training within the defined deadlines 5.Identify and report any quality or compliance concerns on CAPA and AdPromo related, take immediate corrective action as required. 6.Support the execution of regulatory approvals of AdPromo for products in the applicable target markets. 7.Support new product introductions and installed-base activities so they comply with existing and applicable regulations globally.. 8.Support timely closure of customer complaints, field actions, and quality system non-conformances in partnership with functional teams.

Qualifications/Requirements

1.Bachelor's degree in Science or Engineering, Management, Economics and Trading.2.Minimum 3 years professional experience and understanding of Quality System Regulation including CAPA process and deep knowledge on China regulations regarding AdPromo.3.Demonstrated strong relationship with AQSIQ, CFDA and Shanghai FDA.4.Understood the AQSIQ and CFDA regulations and requirements and GEHC procedures.5.Effective report, business correspondence and procedure writing skills. 6.Good problem identification, multivariable analysis and creative resolution aptitude.7.Proven process development and project management skills. 8.Strong computer skills. 9.Ability to communicate using English

Desired Characteristics

1.Demonstrated experience working with CFDA, Shanghai FDA on AdPromo materials approvals.2.Experience in AdPromo materials management process development and issues handling by NC, Investigation and CAPA process3.Experience working in a cross-functional environment and proven ability to influence and build consensus among multiple functions.4.Experience in a global, matrixed organization structure.5.Team player with a global mindset. 6.Strong Change Acceleration skills.

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.