质量高级工程师

Job Description岗位职责:
1. 主导全流程质量管理体系的搭建、优化，包括应对政府机构或药监部门飞行检查。
Lead the establishment and optimization of end-to-end QMS, including handling unannounced regulatory inspections of any organization or government department.
2. 制定产品质量检验标准及新产品开发质量策划，主导试产风险评估与控制方案。
Define product quality inspection standards and new product development quality plans, leading trial production risk assessment and control strategies.
3. 分配质检团队的日常工作任务，提供检测等的技术指导，根据实际情况安排质检员培训。
Assign the daily work tasks of the QC team, provide technical guidance on testing, etc., and arrange training for QC inspectors according to the actual situation.
4. 对采购的原材料、包装材料进行入厂检验，出具检验报告，确保符合质量标准。
Carry out incoming inspection of purchased raw materials and packaging materials and issue inspection reports to ensure compliance with quality standards.
5. 在生产过程中进行关键工序检验、监督生产是否符合工艺规程。
Conduct key the Process Inspection during the production process and supervise whether the production is in accordance with the process regulations.
6. 对最终产品进行成品检验，确保产品符合注册标准和出厂放行标准。
Execute the Finished Product Inspection on the final product to ensure that the product complies with the registration standard and factory release standard.
7. 如实填写检验记录，发现不合格品和违规操作时及时上报质量管理负责人，并参与不合格品评审。
Fill in inspection records truthfully, report to the person in charge of quality management when nonconforming products and irregularities are found and participate in the evaluation of nonconforming products.
8. 协调研发、生产及采购部门推动质量前移，协助管代以及质量负责人主导供应商准入评审及重大质量事故（如客户投诉）的闭环解决。
Coordinate R&D, Production, and Purchasing Department to drive quality upstream. Assist Management Representative and Quality Manager to lead supplier qualification reviews, and resolve critical quality incidents (e.g., customer complaints).
9. 建立供应商评估机制，管理供应商审核及能力提升项目，推动来料质量问题改进闭环。
Develop supplier evaluation mechanisms, manage audit programs, and drive closed-loop improvements for incoming material quality issues.
10. 处理客户投诉并主导根本原因分析，制定预防措施并汇报客户满意度改善进展。
Handle customer complaints, conduct root cause analysis, implement preventive actions, and report on customer satisfaction improvement.
11. 推动精益质量项目以降低质量成本（COQ），优化不合格品处理流程。
Drive lean quality projects to reduce cost of quality (COQ), optimize non-conforming product handling.
Job Requirement岗位要求：
1. 本科及以上学历，机械/电工/生物医学工程或相关专业背景。
Hold a bachelor’s degree or higher in Mechanical/Electrician/Biomedical Engineering or related fields.
2. 具备3年以上医疗器械行业的质量监管经验及2年团队管理或跨部门项目主导经验。
Possesses 3+ years of quality inspection in medical devices industries and 2 years leading teams or cross-functional projects.
3. 精通ISO 13485/GMP标准并持有医疗器械内审员资质。
Demonstrate proficiency in ISO 13485/GMP standards and hold medical device internal auditor certification.
4. 能够独立开展检验工作、指导质检团队并协调生产、研发、供应链资源实现质量目标。
Be capable of conducting inspection work independently and mentor QC teams and coordinate production/R&D/supply chain resources to achieve quality objectives.
5. 拥有质量成本优化意识，及供应商的质量管理经验。
Have an awareness of quality cost optimization and experience in supplier quality management.
6. 具有木材、钢材、电气件的检验经验优先。若有与电工相关专业知识也可优先考虑。
Experience in the inspection of wood, steel, and electrical parts is preferred. Specialized knowledge related to electrical work is also preferred.
7. 具备出色跨部门沟通能力和一定的抗压能力。
Exhibit exceptional cross-functional communication skills and stress resilience.
8. 拥有外企工作经验优先。
Foreign company working experience preferred.
9. 拥有基础的英语读写能力。
Having basic English reading and writing skills.