Key Responsibilities:
1.Ensure compliance with EHS regulations, promoting a safe and sustainable working environment for all employees.
确保符合环境、健康与安全（EHS）法规要求，为所有员工营造安全、可持续的工作环境。
2.Develop and implement manufacturing strategies and processed to optimize productivity and reduce the cost.
制定并实施制造战略和工艺流程，以优化生产效率并降低成本。
3.Monitor and analyze production metrics to identify improvement area and implement corrective actions.
监控并分析生产指标，识别改进领域并落实纠正措施。
4.Ensure all products meet the quality expectations of ISO 13485 standard.
确保所有产品符合ISO 13485标准的品质要求。
5.Lead, mentor and develop a high-performing MFG team, fostering a culture of collaboration , accountability and continuous improvement.
6.Develop budget, capex investment plan, long-term and short term planning processes.
领导、指导并打造高效制造团队，营造协作、责任担当与持续改进的文化。
制定预算、资本支出投资计划及长短期规划流程。
7.Lead the cross-function team to work on developing and implement new process and new manufacturing technology to enhance manufacturing capabilities.
领导跨职能团队，开发并实施新工艺及制造技术，提升生产能力。
8.Drive the process improvement to result in a continuous productivity increase and cost reduction.
推动工艺改进，实现持续增效降本。
9.Very familiar with the key QMS processes including:
Engineering change
DMR
DHR
CAPA
Verification and Validation
Nonconformance management
Supplier quality management
精通以下关键质量管理体系（QMS）流程：
工程变更（Engineering Change）
医疗器械主记录（DMR, Device Master Record）
设备历史记录（DHR, Device History Record）
纠正与预防措施（CAPA, Corrective and Preventive Action）
验证与确认（Verification and Validation）
不合格品管理（Nonconformance Management）
供应商质量管理（Supplier Quality Management）

Required Qualifications:
Education:
1.Bachelor's degree in Engineering, Electronic , Mechanical, or a related technical field.
2.Master’s degree preferred.
教育背景：工程、电子、机械或相关技术领域本科学历。硕士学历优先。
Professional Experience:
1.At least 10 years of experience in operation manager or manufacturing manager or production manager roles in the medical device industry with an international context.
至少10年在国际化医疗器械企业担任运营经理、制造经理或生产经理职位的经验。
2.Proven track record of ISO 13485 or FDA 21 CFR Part 820 QMS implementation or oversight.
具备ISO 13485或FDA 21 CFR Part 820质量管理体系（QMS）实施或监管的成功经验。
3.In-depth knowledge of:
Lean manufacturing /production
ISO 13485
Products/Projects transferring cross countries
ERP
深入掌握以下领域知识：
精益生产（Lean Manufacturing/Production）
ISO 13485标准
跨国产品/项目转移（Products/Projects Transferring Cross Countries）
企业资源计划（ERP）系统
Certifications (preferred):
ISO 13485 Lead Auditor
Lean manufacturing related certification
资质认证（优先考虑）：
ISO 13485 主任审核员（Lead Auditor）
精益生产相关认证（Lean Manufacturing Certification）
Language Proficiency:
1.Excellent written and spoken English is required.
优秀的英语书面及口语能力。
2.Must be capable of writing precise technical documents and effectively communicating with auditors, regulators, and global teams.
能够撰写精准的技术文件，并与审核员、监管机构及全球团队高效沟通。