职位概览
职位编码
WEBCN-2026-000003
工作职能
注册&质量管理
职位类型
Full-time
城市
北京
国家/地区
中国内地
职位内容
介绍
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.
概述
Job Summary
- Collection, record, investigate and feedback on customer complaints to improve customer satisfaction, and impement and report on product recall and adverse event to comply with NMPA regulations.
- Responsible for suppliers management and distributor qualification checking.
- Collect and analyze quality data to feedback potential risk and quality improvement point.
- Support other functions on quality related matters.
岗位职责
Key Accountabilities
- Responsible for handling customer complaint to continuously improve customer satisfication.
- Responsible for adverse event handling, including AE collecting, evaluation, reporting and product maintian in NMPA system.
- Responsible for product recall actions development, implementation and reporting.
- Responsible for quality training on complaint, adverse event and recall to ensure related activites implemenation effectively.
- Conduct customer satisfication survey as required.
- Undertake suppliers management and distributor qualification review.
- Collect and analyze quality data to feedback potiencial risk and opportunities for quality improvement.
- Prepare product periodic assessment reports and submit to NMPA in time.
- Backup for advertisement application and management.
- Backup for product quality checking and recording and handling with un-qualified products.
- Perform other tasks as assigned by line manager.
岗位要求
Minimum Knowledge & Experience required for the position
- Bachelor’s degree or above in Medical device specialty, medical Inspection, Biomedical engineering, Mechanical engineering, Clinical medicine, Pharmaceutical, Life Science, Chemistry, Quality Management, or related.
- Minimum 3-5 years quality working experience, medical device field preferred.
- Well understanding of related NMPA regulations.
If you are interested in constantly learning and being challenged on a daily basis, we encourage you to submit your resume or CV.
Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V.
www.werfen.com
