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We seek an experienced and motivated QA/RA/Process Engineer with a background in Electronics and Mechanics to supervise our aesthetic medical device production in China.
The ideal candidate will have at least five years of experience in the medical device or electronics industry, a strong background in quality assurance, and a comprehensive understanding of the processes required to meet product standards and requirements.
This proposed position includes but is not limited to: qualification/monitoring of critical sub-contractors, maintaining the quality and the procedures of our production line(s), training new workers, ensuring compliance with medical standards and regulatory requirements, and providing technical support.
Key Qualifications:
Education in relevant engineering studies
High English level, speaking and writing
Minimum five years of experience in the medical device and/or electronics industry
Strong quality assurance background, specifically in Supplier Qualification and monitoring
Comprehensive understanding of processes required to meet product standards and requirements
Results-driven and able to work well under pressure
Proficient in presenting technical information
Excellent interpersonal communication skills
Strong teamwork capabilities
Qualified Lead Auditor for Medical Devices (at least ISO 13485 and 21 CFR 820, additional qualification for EUMDR is preferable)
Priority shall be given to knowledge and experience with Low Voltage Directive, GHTF for Process Validation and GAMP5
Experience with Process Validation and Software Tool Validation as per ISO 13485, 21 CFR 820 and GHTF
At least five years of experience
Responsibilities:
Maintain production line quality and procedures, ensuring adherence to industry standards and best practices
Train new workers on production processes and quality assurance protocols
Ensure compliance with medical / non-medical standards and regulatory requirements
Supervise the component acceptance process, guaranteeing that all critical components meet necessary specifications
Provide technical support for any mechanical / electronic issues with the production line and equipment
Supplier Qualification and monitoring
Supplier Audits
Serve as the primary contact point for any quality and production-related issues or concerns
Reports to the QA/RA and/or Engineering Manager, providing updates on production line status, challenges, and progress
我们寻求一位具有电子和机械背景的经验丰富、积极进取的QA/QC/工艺工程师来监督我们在中国的美容医疗器械生产。
理想的候选人将在医疗器械或电子行业拥有至少五年的经验，具有强大的质量保证背景，并对满足产品标准和要求所需的流程有全面的了解。
这一拟议职位包括但不限于：关键分包商的资格认证/监督，维持我们生产线的质量和程序，培训新工人，确保遵守医疗标准和监管要求，以及提供技术支持。
主要资质：
相关工程研究教育
英语水平高，口语和写作能力强
至少五年医疗器械和/或电子行业工作经验
强大的质量保证背景，特别是在供应商资格和监督方面
全面了解满足产品标准和要求所需的流程
注重成果，能够在压力下良好工作
精通技术信息展示
优秀的人际沟通能力
强大的团队合作能力
合格的医疗器械首席审计员（至少ISO 13485和21 CFR 820，***有EUMDR的额外资格）
应优先考虑低压指令、工艺验证GHTF和GAMP5方面的知识和经验
根据ISO 13485、21 CFR 820和GHTF进行过程验证和软件工具验证的经验
至少五年的工作经验
职责：
维护生产线质量和程序，确保遵守行业标准和***实践
对新工人进行生产流程和质量保证协议方面的培训
确保符合医疗/非医疗标准和监管要求
监督部件验收过程，确保所有关键部件符合必要的规范
为生产线和设备的任何机械/电子问题提供技术支持
供应商资格鉴定和监督
供应商审核
作为任何质量和生产相关问题或关注点的主要联络点
向QA/QC和/或工程经理报告，提供生产线状态、挑战和进展的最新情况