北京招聘

工作要求Position Summary：

l Implements quality assurance, quality control, validation and regulation systems in site.
? Ensures the products are accordance with Quality and Regulatory requirements.
? Sets up quality systems to compliant with the requirements from cGMP for drug and medical device, ISO 9000 ,ISO 13485 and CE.
? Continuously responsible, as a member of the Site Leadership Team, for working in a collaborative manner and promoting cross-functional team work, optimum business efficiency, and superior levels of customer service.
? Manages site validation system. Manage site change controls, new initiative/project design reviews and communication with outside technology resources.
? Manages overall Quality control labs to provide full QC capability to organization.
? Provides quality training including cGMP, ISO and others to the site.
? Responsible for handling Medical device product standards, production license and other regulatory requirements.
? Owns the supplier quality and provides technical and quality support to other components supplier assessment with material sourcing team.
? Administrative management responsibilities include budgeting and reporting; employee development and appraisal of team members in the Quality organization; Quality-related capital expenditure recommendation.
? Host customer audits and regulatory audits.
? Makes the final decision of status of products. Hold accountability to ensure the final reports of any Non-conformance, Deviation, Customer complaints and Audits are effective and systematic solved root causes.
? Proactively to drive “Continue Improvement” atmosphere in site, coach and involve in site CI project and drive other “CI” tools throughout the site.

任职要求 Qualification
? Acts as key on site technical advisory resource.
? Performs other duties as required or assigned.
? Spoken and written Mandarin Chinese and English language proficiency is required.
? Strong leadership skills sufficient to effectively manage and develop a high efficient quality team.
? Computer skills including basic proficiency in the Microsoft software.
? A minimum of a B.S in Science Field is required.
? Minimum 5 years Quality Assurance/Control leader experience in Medical Device, Pharmaceutical or Bioscience industries is required.
? Supervisory experience is required.
? Knowledge of cGMP policies and ISO9000, ISO13485 and CE requirements is required.
? Basic knowledge of US FDA and EU agencies requirements is required.
? Good verbal and written communication skills are required.
? Familiar with Medical Devices regulations is preferred.
? A proven track record in developing people and team building is required.
? Ability to work effectively under pressure.
? Attention to detail.
? Analytical thinking abilities- must be able to think logically and progressively.????

公司地点：北京市怀柔区桥梓开发区内，公司免费提供宿舍&工作餐。

杰普莱斯（北京）公司从事研究、开发、生产医疗诊断用品，自成立以来，每年向世界糖尿病人提供近12亿只采血针，同时提供采血笔、酒精棉等多种医疗用品。
公司产品全部出口，产品远销美国、英国、印度、台湾和中东，是目前世界第二大采血针生产基地。
公司坐落于风景秀丽的怀柔， 总占地面积18144平方米，厂房面积7140平方米，拥有生产设备50余台，生产模式按照美国《当前医疗企业优秀作法》实施流水线。依据ISO13485体系要求，公司建立和运行了医疗器械管理体系并在2005年12月获得由德国莱茵技术公司颁发的ISO9000，ISO13485体系认证和产品CE证书