上海招聘

Philips Healthcare医疗集团，上海APEX电子科技有限公司
招聘Mechanical Engineer, R&D
For over 10 years, Shanghai APEX Electronics Technology Co., has been a leading company in design, develop and manufacture medical ultrasound transducer for variety of applications. The company has become the Philips Healthcare member since 2010 and continues actively to provide high quality, high performance products to medical ultrasound customers.


Purpose of this role:
Leader for all Quality and Regulatory functions supporting the Apex Ultrasound Business located in Shanghai, China. This role is responsible and accountable for quality and regulatory activities supporting Operations, new product development, product transfer, and sustaining projects. In addition, this role will interact with the Apex Management Team, and the Ultrasound Q&R organization located in the USA to ensure continues compliance to harmonized systems, procedures, and applicable regulations.


Key Areas of Responsibilities:
- Identify, foster and grow a harmonized quality and regulatory organization across Ultrasound BIU. Liaise and leverage resource with other RA organizations within IS & PH.
- Product Development portfolio: Provide timely QA & RA support to the planned US product development efforts to assure on time product release per R&D and Market agreed timelines.
- Operations: Provide adequate QA support to the operation team based in Shanghai to ensure timely shipment of high level of quality products to the customers.
- Provide leadership and mentoring to the Quality assurance and quality control team.
- Regulatory Compliance: Support compliance, simplification and Harmonization of regulatory procedures at Apex
- Q&R team development: Establish and execute plans to address development needs, growth, and succession planning.
- Metrics: Develop and implement appropriate quality and regulatory metrics to facilitate tracking and monitoring of key element of the quality system, compliance, and regulatory activities.
- Product Transfers: Liaise and support product transfer project from other US facilities to Apex.
- Management Representative: Direct contact and representative for Apex when working with CFDA and other regulatory agencies.


Requirements:
- BS in engineering, life sciences, MS or MBA preferred
- 10 years Medical device Quality and Regulatory experience working in China with CFDA, FDA, and ISO.
- 3 to 5 years leadership/managerial experience in Q&R field.
- Expertise in Quality and regulatory affairs strategy & processes, for China manufacturers.
- Regulatory Compliance requirements knowledge for CFDA, US, EU, Japan, and emerging markets.
- Managing CFDA, Notified Body, and other agency meetings.
- Surveillance of industry trends to assure continues compliance.
- Fluent English (Read, Write, Speak)

    上海爱培克电子科技科技公司（PHILIPS集团全资子公司），是源于1997年10月在上海浦东张江高科技园区注册成立的企业。公司建立以来依托所拥有的自主知识产权的先进技术，不断开发市场需求以及潜在的新产品，公司拥有较强的技术与管理团队，并拥有注册专利十多项。

    在十几年的艰苦奋斗中，爱培克公司不断地获得国内先进科研成果，及时地掌握国内外的技术应用信息并与美国、丹麦、加拿大、德国、法国等世界知名企业建立了业务关系。从05年起爱培克公司的产品品种迅速增加，与此同时公司的销售额也得到了成倍的增长。

    2006年爱培克公司被评为“上海市高新技术企业”，又于08年第一批被上海市科委重新认定命名为“上海市高新技术企业”。2008年成功申请到上海市科技型中小企业创新基金，2010年获得了上海市科委批准的“科技小巨人培育型企业”工程项目。
    2006年飞利浦医疗系统（Philips Healthcare），在经过将近两年的时间，对全球范围内有关医疗超声企业作了调查和评估，决定选择上海爱培克电子科技有限公司作为“联合研发、联合生产的长期战略合作伙伴”。 爱培克公司与飞利浦医疗医系统经过了近五年的合作，较快的拓展了国外市场。公司为了能使医疗超声探头更快的进入国际B超行业的前列，从长远社稷，决定依靠飞利浦多年来的先进技术与创新、先进的管理理念及其价值观，来带动中国超声医疗产业的发展 ，由此飞利浦集团于2010年7月28日收购了上海爱培克电子科技有限公司。

    如今，上海爱培克科技公司已是飞利浦集团下的一员，是飞利浦“健康舒适，优质生活”的一家多元化公司。在同飞利浦融合的过程中，我们会把飞利浦创新的技术，先进的管理融入爱培克，大力发展我们的OEM和飞利浦的业务，我们会更加关心员工的成长，企业的品牌，及社会的责任。我们全体员工会遵循飞利浦“精于心，简于形”的品牌承诺，在各自的岗位上，为实现使人们拥有更健康、更快乐、更有价值的生活而努力。

    荷兰皇家飞利浦电子公司是一家“健康舒适、优质生活”的多元化公司，致力于通过及时地推出有意义的创新来改善人们的生活质量。作为全球医疗保健、优质生活和照明领域的领导者，飞利浦基于对客户需求的了解以及“精于心简于形”的品牌承诺，将技术和设计融入到了以人为本的解决方案中。

    总部位于荷兰的飞利浦公司在全球60多个国家拥有大约116,000名员工，其2008年的销售额达263.85亿欧元，并在心脏监护、紧急护理和家庭医疗保健、节能照明解决方案和新型照明应用、以及针对个人舒适优质生活的平板电视、男性剃须和仪容产品、便携式娱乐产品以及口腔护理产品等领域均居于世界领先地位。

    公司拥有注册专利55,000项，充分显示了公司的创新本质。在当今世界，科技日益影响到人们生活的方方面面。我们希望通过“精于心简于形”的品牌承诺，为消费者提供“创新先进、轻松体验和为使用者需求而设计”的解决方案，使人们从创新和技术进步中获益。

    飞利浦的产品早在1920年就进入了中国市场，1985年在中国设立第一家合资企业。作为在中国的跨国公司中的佼佼者，我们的业务遍及600多个城市，拥有23家合资及独资企业，共有15,000多名员工。

    上海爱培克电子科技有限公司目前有员工260人，2011年销售额1.6亿。