职位描述：
1. 负责落实和完善医疗器械研发和生产质量体系，确保体系运行更好的持续符合相关要求；
o Responsible for implementing and improving the medical device R&D and MFG quality system, ensuring its continued compliance with relevant requirements.
2. 审核医疗器械产品研发过程中的设计历史文件；
o Review design history files during the development process of medical device products.
3. 配合开展医疗器械研发相关法规及产品标准的宣传和培训；
o Assist in the promotion and training of medical device R&D related regulations and product standards.
4. 协助开发人员完成设计开发转换和注册申报工作；
o Assist developers in completing design transfer and registration application tasks.
5. 参加设计转移会议，负责落实和完善医疗器械生产质量体系，确保生产体系运行符合相关要求；
o Attend design transfer meetings and be responsible for implementing and improving the medical device production quality system, ensuring its compliance with relevant requirements.
6. 管理和审核医疗器械产品生产制程中的批记录及相关文件；
o Manage and review batch records and related documents in the medical device production process.
7. 对医疗器械研发和生产过程中的体系合规性和有效性进行评估，参与内部审核和管理评审，及时反馈结果并提供质量改进意见；
o Evaluate the compliance and effectiveness of the quality system during the medical device development and MFG process, participate in internal audits and management reviews, promptly provide feedback and quality improvement suggestions.
8. 报告医疗器械研发和生产体系的运行情况，推动设计缺陷和生产不符合的解决；
o Report on the operation of the medical device R&D and MFG quality system and drive the resolution of design defects and MFG NCs.
9. 完成领导交办的其他工作任务。
o Complete other tasks assigned by leadership.
任职要求：
1. 本科及以上学历，机械、电气、电子、医药等相关专业；
o Bachelor's degree or above in Mechanical, Electrical, Electronic, Pharmaceutical or related fields.
2. 至少5年医疗器械研发或生产体系工作经验，熟悉ISO 13485质量体系及医疗器械法规要求，有质量管理体系编写或导入经验者优先；
o At least 5 years of experience in medical device R&D or production quality systems, familiar with ISO 13485 quality system and medical device regulatory requirements, with experience in quality management system writing or implementation preferred.
3. 具备优秀的书面表达能力和沟通能力，良好的团队协作精神；
o Excellent written communication skills and interpersonal skills, with good team collaboration spirit.
4. 诚实守信，严谨认真；
o Honest, trustworthy, meticulous, and serious.
5. 能够适应长期出差（宁波、厦门等）进行供应商体系培训或审核。
o Able to adapt to long-term business trips (Ningbo, Xiamen, etc.) for supplier system training or audits.