Key Responsibilities include:
主要職責：
?Drive maintenance and implementation of the Hologic China Quality Management System Maintenance to compliance CNDA GSP requirement and Hologic corporate QMS compliance
負責維護豪洛捷中國質量管理體系，以保證運營的合規性和對全球質量管理體系的符合性
?Drive continuous improvement of the quality system & process using quality performance information, in conjunction with information from period internal audits, CAPA, QMR…..
利用內審，管理評審和CAPA等機制，負責豪洛捷中國質量管理體系的持續改進和流程優化。
?uate regulation compliance status, drive strategic projects define to mitigate risk and drive execution.
根據法規符合性的評估，定義改進項目以降低風險并控制/執行項目
?Post market complaint handling, adverse event uation and reporting, recall reporting and implementation tracking
后市場客戶投訴的處理、不良事件的評估和報告、召回的報告和實施監控
?Product labelling control to compliance related country regulation requirement
產品標簽說明書控制，以符合本地區法規要求，并降低
?Plan & Assign & Tracking online learning to compliance CFDA regulation, ISO13485 standard and Hologic corporate SOP requirement.
策劃和追蹤符合CNDA法規要求，ISO13485標準要求和豪洛捷總公司質量流程相關要求的在線培訓
?Supplier/Dealer uation monitoring and audit, when necessary
供應商/經銷商評估和監控，以及必要時的現場審核
?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.
根據數據分析，評估當前操作流程以改進
?May include other duties as required
其他所需工作分配
Qualifications & Experience
經驗/需求：
?At least 8 years working experience in Medical device industry with 2 years people management experience
至少8年的醫療器械行業工作經驗，并有至少2年的團隊管理經驗
?Good written and verbal communication skills in Chinese and English
良好的中英文溝通能力
?Independent judgment and analysis and team coaching capability required.
獨立判斷分析能力和對員工的輔導能力
?Knowledge of Agile PLM software and Oracle is an advantage
優先對Agile和Oracle有使用經驗的人選
?Good organizational skills
良好的組織協調能力
?Excellent attention to detail required
追求細致的工作精神
?Computer literate: able to use Microsoft Office suite
電腦操作：能操作微軟辦公軟件
?Experience in a regulated environment an advantage.
優先醫療器械法規行業工作經驗

Education 教育
?University/College above in Engineering/IVD test/bioengineering/ Biotechnology major preferred
大學本科及以上，優先理工科/檢驗學/生物醫學工程/生物技術等專業

公司簡介：
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.

我們是豪洛捷

豪洛捷公司（納斯達克代碼：HOLX）是一家領先同儕，集研發、制造和供應優質醫療影像系統、診斷和外科手術產品于一體的公司，以服務全球婦女醫療健康需求為己任。
豪洛捷公司致力于幫助全球各地婦女得以享受更健康、更長壽的生活。這就是豪洛捷存在之意義和唯一專注的焦點。我們追求的每次突破、設計的每個方案、和決定的每項投資都為邁向這目標。
我們為此自豪，同時也意識到作為行業領導者應有的道義。我們認為，當今婦女所面臨的醫療健康問題值得并且需要一家充滿激情和奉獻精神的公司來服務。
我們的核心業務集中在乳腺健康、診斷產品、婦科和骨骼健康方面。