一、Responsibility岗位职责：
1. Quality Management System (QMS): ISO13485 maintenance, FDA QMSR compliance, CAPA management, Change management.
质量管理体系（QMS）：ISO13485 体系维护，确保符合 FDA QMSR 法规要求，CAPA（纠正预防措施）管理，变更管理。
2. Internal & External Audits: Plan and coordinate internal audit activities,Prepare audit reports and follow-up actions, Support external audits conducted, Track audit findings and verify completion of corrective actions.
内外部审核：策划并协调内审工作，编制审核报告并跟进整改行动，配合开展外部审核，跟踪审核发现项，验证纠正措施完成情况。
3. Document Control: Maintain controlled documents and quality records in Unipoint, Ensure document revision control and timely release of approved documents, Support ECN/ECO implementation and document change activities.
文件控制：在 Unipoint 系统中维护受控文件与质量记录，管控文件版本，确保批准文件及时发放，支持 ECN/ECO 执行及文件变更相关工作。
4. Complaint & NCR: Customer complaint investigation, NCR/SCAR follow-up.
客诉与不合格项：客户投诉调查，NCR/SCAR 跟进。
5. Quality Control Support: QC procedure maintenance, QC training, Review QC reports and quality metrics.
质量控制支持：QC 程序文件维护，QC 相关培训，审核 QC 报告及质量指标。
6. Continuous Improvement: NPI（New Product Introduction）, quality support，eg，translate English ECN,ECO to Chinese, Process improvement, Equipment validation.
持续改善：NPI（新产品导入），质量支持，例如英文 ECN、ECO 文件翻译成中文，工艺改善，设备验证。

二、Qualification任职要求：
1. Bachelor’s degree in engineering, Quality Management, Biomedical Engineering, Manufacturing, or related field.
工程、质量管理、生物医学工程、制造或相关领域的学士学位。
2. Minimum 2 years of experience in Quality Assurance within a medical device or regulated manufacturing environment.
至少 2 年医疗器械或受法规管控生产环境下的质量保证工作经验。
3. Good team spirit, cooperative.
良好的团队精神和协作能力。
4. Good working attitude, conscientious.
良好的工作态度，做事认真负责。
5. Good English speaking, listening, and written.
良好的英语听说读写能力。
6. Received quality related training will be good, such as internal audit, ISO 13485,QMSR.
接受过内审、ISO 13485、QMSR 等质量相关培训者优先。
7. Rich knowledge of SPC,6Sigma, Gauge R&R, QC tools.
精通统计过程控制（SPC）、六西格玛、测量系统分析（Gauge R&R）及各类质量控制工具。
8. Rich Medical device quality control experience, know ISO13485 rules, or have knowledge of FDA QMSR requirements.
具备丰富的医疗器械质量管控经验，熟悉 ISO13485 规范，或了解美国 FDA 质量体系法规（QMSR）要求。
9. Polite and in good manner, comply with company discipline.
为人有礼，遵守公司规章制度。