北京招聘

Key Responsibilities include:

主要职责：

• Responsible for Hologic Quality Management System Maintenance from region compliance aspect.

负责维护豪洛捷质量管理体系，以保证区域运营的合规性

• Responsible for processing BOM/Part, Quality Document maintenance in PLM & ERP system to meet required turnaround times, CFDA/MHLW/TGA/KFDA regulation, ISO13485 standard and Hologic corporate SOP. Support and training of change originators to ensure change controlled in accordance with Hologic Quality system

负责BOM/物料，质量文件在PLM和ERP系统中的维护，以符合公司运营要求、CFDA/厚生省/TGA/KFDA等法规要求、ISO13485标准要求、和豪洛捷总公司流程的要求。支持和培训变更需求相关方，以保证变更控制符合豪洛捷质量体系要求。

• Plan & Assign & Tracking online learning to compliance CFDA/MHLW/TGA/KFDA regulation, ISO13485 standard and Hologic corporate SOP requirement.

策划和追踪符合亚太区法规要求，ISO13485标准要求和豪洛捷总公司质量流程相关要求的在线培训

• Supplier/Dealer evaluation monitoring and audit, when necessary

供应商/经销商评估和监控，以及必要时的现场审核

• Monitoring Product quality status through incoming inspection, shipment confirmation, complaint handling process, and communicate with R&D/MFG when necessary to drive product quality improvement and reduce customer complaint

通过入库验收、出库复核、客户投诉等过程，监控产品质量状态，并于必要时和研发/生产沟通以督促产品质量的提高

• Product labelling control to compliance related country regulation requirement

产品标签说明书控制，以符合本地区法规要求

• Follows standard practices and procedures when analyzing situations or data. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

根据数据分析，评估当前操作流程以改进

• May include other duties as required

其他所需工作分配

Qualifications & Experience

经验/需求：

• Good written and verbal communication skills in Chinese and English

良好的中英文沟通能力

• Use of independent judgment and analysis required.

独立判断分析能力

• Knowledge of Agile PLM software and Oracle is an advantage

优先对Agile和Oracle有使用经验的人选

• Good organizational skills

良好的组织协调能力

• Excellent attention to detail required

追求细致的工作精神

• Computer literate: able to use Microsoft Office suite

电脑操作：能操作微软办公软件

• Practical experience with online learning management tools an advantage.

优先在线教育经验者

• Experience in a regulated environment an advantage.

优先医疗器械法规行业工作经验

Education 教育

· University/College education in Engineering/IVD test major preferred

大学本科毕业，优先理工科/检验学科背景

Hologic, Inc. is a leading developer, manufacturer and supplier of premium molecular diagnostic products and services that are used to diagnose human diseases, screen donated human blood and to aid in biomedical research. Hologic is also a leader in the development, manufacturing and sales of medical imaging systems and biopsy devices as well as surgical and treatment products, with an emphasis on serving the healthcare needs of women. Our business is dedicated to impacting the lives of people across the globe through the early detection of disease, improved diagnosis and less invasive treatments.
There’s never been a more exciting time to join us.
豪洛捷是一家领先同侪，集研发、制造和供应优质分子诊断产品和服务、医疗影像系统、外科手术产品于一体的公司，以服务全球***医疗健康需求为己任。豪洛捷公司致力于通过早期诊断、微创的治疗方式帮助全球***得以享受更健康、更长寿的生活。目前hologic亟需优秀人才的加入。

Bright people, working together to pioneer advances in human health care, have created Hologic's success. Our company believes that people are our greatest asset and only by recruiting, hiring, developing and retaining the most talented employees can we continue to be successful.
有远见的人一起致力于健康诊断成就了今天的Hologic。我们坚信，人才是公司宝贵的财富，只有通过招聘、培训、发展、保留***的人才，我们才能持续成功。

Our work atmosphere is stimulating, innovative and customer focused. We provide employees with state-of-the art tools and technology, a collaborative and passionate work environment and the ability to make a dramatic difference in the world of healthcare.
我们的工作氛围是促进创新和以客户为中心。我们为员工提供***的工具和技术，合作和充满激情的工作环境，以提升世界各地的医疗保健水平。

We are headquartered in Massachusetts and have centers of operation across North America, Europe, Central America, Australia and Asia. We have the strength and resources of a billion dollar company and the vision of leaders committed to a broad spectrum of health issues.
公司总部位于马萨诸塞州，在北美、欧洲、拉丁美洲、澳大利亚、亚洲设置了运营中心。我们将集中公司资源致力于提升全球的健康水平。

We are rapidly growing and yet we have never been more focused – on our people, on our growth, on our future. There has never been a more exciting time in our company’s history. Visit our website to learn more about the many career opportunities we have available today.
我们正在迅速成长，我们将更加关于于人民、成长与未来。这是一个激动人心的历史时刻，可以访问我们的网站以了解更多的职业生涯的机会。

Hologic has commercial organization, R&D, MFG facilities in China. China Headquarter is in Beijing. We aim to build China Organization an exciting place to work and grow professionally.
豪洛捷在中国设置了完整的商业机构，包括研发、生产等。总部位于北京，我们致力于打造积极的、专业的商业运营机构。