天津招聘

Business Segment

Healthcare Quality

About Us

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Role Summary/Purpose

A Quality and Regulatory Assurance Manager ensures product and process compliance to regulatory requirements for the designated product line(s) by managing the quality system design, controls and continuous improvement and establishing best practice standards in the development of new products and post-market support of products.

Essential Responsibilities

•Fully accountable lead to report recalls and adverse events to CFDA, Shanghai FDA, Jiangsu FDA, AQSIQ and/or other authorities. •Identifying, accessing and managing regulatory risk proactively and providing senior management with key data from RA to help drive decisions. •Liaising with internal personnel and external regulatory bodies to ensure appropriate input into regulatory strategy and ensure approval within milestone goals for submissions for assigned projects •Managing quality systems, processes and procedures to assure product quality and safety. •Assisting the QARA Director in implementation of corrective actions that are raised by deviations, internal audit or regulatory inspection. •Engaging strong intradepartmental and cross-functional/organizational relationships to drive Quality System Requirements (QSRs). •Working closely with other functional areas (e.g. Marketing, Engineering, Manufacturing, Service) to ensure compliance to applicable regulations in the areas of Design, Service and Manufacturing •Leading and supporting continuous improvement activities assigned, which may include such areas as: Standards compliance, Risk management, and metrics development/implementation. 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.Ensure new product introductions and installed-base activities comply with existing and applicable regulations globally. 5.Complete all management reviews in accordance with management controls procedures. 6.Ensure on-time reporting of adverse events and recalls globally. 7.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 Science or Engineering, Management, Medical Device Technology. 2.Minimum 4 years professional experience and understanding of product development, manufacturing, quality control and servicing in the medical equipment or pharmaceutical industry. 3.Hands-on experience with FDA, QSR, ISO, MDD and/or other international quality systems requirements.4.Proven track record in performing external and internal audits. 5.Ability to read, analyze, and interpret business plans, technical procedures and governmental regulations. 6.Effective report, business correspondence and procedure writing skills. 7.Good problem identification, multivariable analysis and creative resolution aptitude.8.Proven process development and project management skills. 9.Strong computer skills. 10.Ability to communicate using English

Desired Characteristics

1.Experience working with CFDA, Shanghai FDA, Jiangsu FDA, AQSIQ, and/or other authorities.2.Demonstrated experience working in a cross-functional environment and proven ability to influence and build consensus among multiple functions.3.Experience in a global, matrixed organization structure.4.Professional certification as a Lead Auditor. 5.Six Sigma training and/or certification6.Team player with a global mindset. 7.Strong Change Acceleration skills. 8.Experience in building a Quality System from ground up.

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.