Summary of Duties and Responsibilities
主要职责
Quality Management System Development and Maintenance:
质量管理体系建设与维护：
Assist in establishing, implementing, and maintaining the company's quality management system to ensure compliance with relevant supply regulations and standards.
协助建立、实施和维护公司的质量管理体系，确保其符合医疗器械经营质量管理相关法规。
Regularly review and update quality management documents to ensure their accuracy and compliance.
定期审查和更新质量管理文件，确保其准确性和合规性。
Product Quality Control:
产品质量控制：
Responsible for communicating with 3PL, regarding the quality control of medical device during the warehousing and logistics processes, providing the manufacturing date, the expiration date, COC/COA, ensure they meet quality standards.
负责与医疗器械第三方物流沟通，包括医疗器械产品在仓储物流物流环节的产品质量进行控制，提供生产日期、有效期、合格性证明文件等，确保产品符合质量标准。
Monitor and record product quality issues, providing timely resolution and feedback.
监控和记录产品的质量问题，及时解决和反馈。
Responsible for the update of work Instruction and quality agreements between Hologic and 3PL, auditing the quality assurance capabilities of 3PL.
负责更新与医疗器械第三方之间的工作程序、质量协议，并对其质量保证能力审核。
GSP required IT system and EDI:
GSP关于计算机系统的要求：
Responsible for the implementation of GSP requirements of IT systems in the Hologic Oracle system.
推动落实 GSP对于计算机系统的要求在Hologic Oracle 系统的实施。
Responsible for the implementation of GSP IT- system requirements between 3PL and Hologic, regarding the EDI of master data, logistic records, and support system upgrades and validation.
负责推进落实与第三方物流与Hologic计算机系统主数据、仓储物流记录等对接的相关要求、支持系统升级验证。
Adverse Event Reporting:
不良事件上报：
Maintain company and product information in the NMPA medical device adverse event monitoring system.
维护国家医疗器械不良事件监测系统的公司及产品信息。
Monitor the user/customer AE reports in the NMPA medical device adverse event monitoring system, track the investigation progress of the Service team, and submit the investigation and evaluation report.
监测国家医疗器械不良事件监测系统中用户不良事件上报信息，追踪售后服务团队的调查进度，提交调查评估报告。
Report domestic and foreign medical device adverse events within the time limits required by regulations.
按法规要求时限上报境内、外医疗器械不良事件。
Authority traceability system and QMS annual self-inspection report:
药监追溯系统及年度自查报告：
Timely Update the data of Class II&III medical devices in the authority traceability system, as well as suppliers and distributors information.
及时在追溯系统更新的二、三类医疗器械，以及供应商、经销商信息。
Submit the annual self-inspection report of the previous year to the territory authorities before March 31 each year.
每年3月31日前向监管部门递交前一年的年度自查报告。
Implement the Regulations for the Supervision and Administration of Medical Devices, maintain the company’s business licenses, coordinate and monitor the implementation of Instructions for use and labels of medical devices, and assist in the internal and external supervision, inspection and audit.
贯彻执行《医疗器械监督管理条例》，维护公司经营资质，协助内外部监督、检查、审核。
Release QMS related training courses in E-learning system, determine the training target and tracks the completion.
在E-learning系统中发布质量管理体系相关培训课程，确定培训目标并跟踪完成情况。
Regulations and Standards Compliance:
法规与标准的遵循：
Track updates to domestic and international medical device-related regulations and standards to ensure product and operational compliance.
跟踪国内外医疗器械相关法规和标准的更新，确保公司产品和运营的合规性。
Maintain good communication with regulatory agencies to ensure the company's compliance in the regulatory environment.
与监管机构保持良好沟通，确保公司在监管环境中的合规运营。
EDUCATION
Bachelor's degree or above.
本科以上学历；
Medical device related major (Including medical devices, biomedical engineering, mechanics, electronics, medicine, bioengineering, chemistry, pharmacy, nursing, rehabilitation, laboratory science, computer science, law, and management, etc.).
医疗器械相关专业（包括医疗器械、生物医学工程、机械、电子、医学、生物工程、化学、检验学、计算机等专业）。
QUALIFICATIONS & EXPERIENCE
More than five years of experience in medical device supply business QA相关医疗器械经营质量监管QA经验5年以上；
Familiar with the relevant regulations of medical device supply business熟悉医疗器械经营质量管理相关法规；
Strong communication and coordination skills较强的沟通及协调能力；
Knowledge of Agile PLM software and Oracle is an advantage对Agile和Oracle有使用经验的人选；
Excellent English speaking and writing skills.优秀的英语听说读写能力。
Adapt to short-term travel能适应短期出差