職務概況
月薪NT$ 45,000~60,000
台南市新市區
條件要求
工作經歷
3年以上
職務描述
1. Quality Assurance Management:
-Develop, implement, and maintain quality assurance policies and procedures in line with ISO 13485 and FDA regulations.
-Conduct regular reviews and updates of quality documentation, including SOPs and work instructions.
2. Regulatory Compliance:
-Ensure all products comply with relevant regulatory standards and requirements.
-Prepare for and participate in audits conducted by regulatory bodies and notified organizations.
3. Collaboration with Cross-Functional Teams:
-Work with R&D, manufacturing, and supply chain teams to ensure quality is embedded in all phases of product development.
-Review and approve design documentation, risk management files, and validation protocols.
4.Non-Conformance and CAPA Management:
-Investigate non-conformances and coordinate corrective and preventive actions (CAPA) to address quality issues.
-Analyze quality data and trends to identify improvement opportunities.
5. Continuous Improvement Initiatives:
-Lead and participate in quality improvement projects and initiatives.
-Monitor key quality metrics and report findings to management.
需求人數
1~1人
學歷要求
大學(學院)以上
上班時段
8:30~17:30
休假制度
週休二日
工作技能
Planning and Implementation of Quality Management System
規劃並執行品質管理系統
職務類別
QA / QC Engineer
ISO / Quality Assurance Staff
QA / QC Supervisor
台南市新市區
其他醫療保健服務業
美萌科技股份有限公司設立於民國97年10月20日，公司目前致力於齒顎矯正醫療器材設計、開發及製造，產品包含金屬矯正器、陶瓷矯正器、透明牙套、配件等。美萌一直秉持不斷開發創新齒顎矯正產品，盼成為國際潮流領導先驅。
我們重視每一位員工，除了有良好工作環境、也提供學習及成長的空間，歡迎南部優秀的朋友一起加入美萌科技股份有限公司的工作行列。
