体系工程师 QA System & Document Control Engineer

1. Design, implement, and continuously improve ISO-compliant management systems, ensuring cross-standard synergy and operational efficiency. 设计、实施并持续改进符合 ISO 标准的管理系统，确保跨标准协同作用和运营效率。

2. Plan and conduct internal audits (system, process, product) annually, deliver audit reports, and drive CAPA (Corrective and Preventive Actions) closure. 每年计划和开展内部审计（系统、流程、产品），提供审计报告，并推动 CAPA（纠正和预防措施）收尾。

3. Manage external audits (certification bodies, customer audits), lead non-conformance resolution, and maintain valid certifications. 管理外部审计（认证机构、客户审计），领导不合规问题解决，并维护有效认证。

4. Monitor updates to ISO, RBA, and regional regulations, and adapt policies/procedures proactively. 监控 ISO、RBA 和区域法规的更新，并主动调整政策/程序。

Document Control & Lifecycle Management文档控制和生命周期管理

5. Establish and enforce document control procedures, covering creation, review, approval, distribution, revision, obsolescence, and archiving. 建立和执行文档控制程序，包括创建、审查、批准、分发、修订、淘汰和归档。

6. Ensure traceability, version control, and compliance of technical documents (e.g., medical device technical files) and quality records. 确保技术文档（例如医疗器械技术文件）和质量记录的可追溯性、版本控制和合规性。

7. Administer electronic document management systems (e.g., SharePoint, Documentum), optimizing access controls and audit trails. 管理电子文档管理系统（例如 SharePoint、Documentum），优化访问控制和审计跟踪。

RBA Compliance RBA 合规

8. Implement RBA Code of Conduct across operations and supply chain. 在整个运营和供应链中实施 RBA 行为准则。

9. Lead RBA audit preparation, execution and corrective action follow-up. 领导 RBA 审计准备、执行和纠正措施跟进。

10. Deliver RBA training programs to enhance organizational awareness.

提供 RBA 培训计划以提高组织意识。

ESG & CSRD Integration ESG 和 CSRD 整合

11. Support ESG strategy development and KPIs for sustainability. 支持 ESG 战略制定和可持续发展 KPI。

12. Track CSRD requirements and draft ESG disclosures. 跟踪 CSRD 要求并起草 ESG 披露文件。

13. Collaborate on sustainability initiatives (e.g., circular economy). 就可持续发展计划（例如循环经济）进行合作。

14. Other tasks assigned by line manager.主管安排的其他工作和职责。