Key Responsibilities include:
主要职责：
•Drive maintenance and implementation of the Hologic China Quality Management System Maintenance to compliance CNDA GSP requirement and Hologic corporate QMS compliance
负责维护豪洛捷中国质量管理体系，以保证运营的合规性和对全球质量管理体系的符合性
•Drive continuous improvement of the quality system & process using quality performance information, in conjunction with information from period internal audits, CAPA, QMR…..
利用内审，管理评审和CAPA等机制，负责豪洛捷中国质量管理体系的持续改进和流程优化。
•uate regulation compliance status, drive strategic projects define to mitigate risk and drive execution.
根据法规符合性的评估，定义改进项目以降低风险并控制/执行项目
•Post market complaint handling, adverse event uation and reporting, recall reporting and implementation tracking
后市场客户投诉的处理、不良事件的评估和报告、召回的报告和实施监控
•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，并降低
•Plan & Assign & Tracking online learning to compliance CFDA regulation, ISO13485 standard and Hologic corporate SOP requirement.
策划和追踪符合CNDA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 uation 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
•Follows standard practices and procedures when analyzing situations or data. Exercises judgment within generally defined practices and policies in ing 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：
•At least 8 years working experience in Medical device industry with 2 years people management experience
至少8年的医疗器械行业工作经验，并有至少2年的团队管理经验
•Good written and verbal communication skills in Chinese and English
良好的中英文沟通能力
•Independent judgment and analysis and team coaching capability required.
独立判断分析能力和对员工的辅导能力
•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
•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 above in Engineering/IVD test/bioengineering/ Biotechnology major preferred
大学本科及以上，优先理工科/检验学/生物医学工程/生物技术等专业

公司简介：
We Are Hologic

Hologic, Inc. (Nasdaq: HOLX) is a leading developer, manufacturer and supplier of premium diagnostic products, medical imaging systems, and surgical products dedicated to serving the healthcare needs of women throughout the world.


At Hologic, we are on a mission: to help women everywhere lead longer, healthier lives. It is our reason for being and the single focus of every breakthrough we pursue, every solution we design, every investment we make.
We are proud of our achievements and conscious of the responsibility that our leadership position brings with it. We believe that the health issues facing women today deserve and demand the singular dedication of a passionate company.
Our core business units are focused on breast health, diagnostics, GYN surgical, and skeletal health.

我们是豪洛捷

豪洛捷公司（纳斯达克代码：HOLX）是一家领先同侪，集研发、制造和供应优质医疗影像系统、诊断和外科手术产品于一体的公司，以服务全球妇女医疗健康需求为己任。
豪洛捷公司致力于帮助全球各地妇女得以享受更健康、更长寿的生活。这就是豪洛捷存在之意义和唯一专注的焦点。我们追求的每次突破、设计的每个方案、和决定的每项投资都为迈向这目标。
我们为此自豪，同时也意识到作为行业领导者应有的道义。我们认为，当今妇女所面临的医疗健康问题值得并且需要一家充满激情和奉献精神的公司来服务。
我们的核心业务集中在乳腺健康、诊断产品、妇科和骨骼健康方面。