北京招聘

职位描述：
Responsibilities/Essential Duties:
Be responsible for establishing, implementing and maintaining the quality management system in China.
Create and maintain company quality documentation, such as quality policies, procedures, SOP, records & etc.
Capture the local medical device regualatoins and vigilance reports and ensure the regulatory compliance.
Present management team QMS performance and any quality trending.
Documents product complaints into the database for trending and analysis, and ensures the complaint process is completed in accordance with corporate procedures.
Ensures that all product complaints are screened for potential safety issues, reported accurately, and complaints are closed out in a timely manner. Partners with manufacturing facilities to analyze failure.
Coordinates the return of products samples; performs visual inspection and preliminary investigations related to product issues; forwards samples and preliminary investigation reports to responsible departments; reviews the responses; and notifies the customer of the result.
Partners with Field Service, Logistic, Planning, Marketing, Manufacturing, RA and Sales to help resolve customer issues.
Quality supervision of 3rd party logistics in China, performing regular inspections and assessments and implementing necessary corrective actions to ensure that warehouse operations comply with local government requirements and company policies.
Ensure non-comfirming products be controlled and disposed correctly and timely.
Act on internal and external audit through out company and make sure all detected defects be addressed.
Maintain CAPA system to make sure continious improvement.
Perform advese event and product recall reporting and implemetation it timely.
Develop training program to build quality awareness in the company.
Actively provide individual contributions in problem solving efforts to improve quality.
Assist AP QA Manager for qualilty affairs deployment in AP region.
The incumbent may be asked to perform other function-related activities in addition to the above mentioned responsibilities as reasonably required by business needs.

Requirement:
At least 5 years experience in a medical device environment presenting and defending quality compliance programs both domestically and internationally.
Experience in post-surveillance or product vigilance.
Managerial position with strong people management skills.
Experience in conducting QS audits, familiar with ISO9001, 13485, medical device related regulations.
Travel Expectations: Regular 15-30% 举报 分享

唯美（上海）管理有限公司是美国血液技术公司（Haemonetics Corporation）在中国境内设立的子公司。我们的产品组合包括器械、信息管理和咨询服务，针对血液供应链的所有环节 － 从血浆和血液采集机构到医院 － 提供血液管理方案。 我们坚信，通过合适的血液管理，我们的产品和服务能更好地帮助客户让不用输血的患者不输血，让需要输血的患者输合适的血。
我们的成功始于 1971 年，从那时起，我们提供的设备和耗材就改变了血浆和血液采集中心以及手术室采集和处理血液的方式。 随着行业需求的变化，我们从专注于血液处理系统的医疗器械公司，成为全球领先的血液管理方案供应商。