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.

1. 開立生產需求單據(工單、請購單)。 2. 生產資料整理及備份。 3. 跨部門(產線)支援生產及文件傳遞。 4. 訓練為生管工作之代理人。 5. 主管交辦事宜及相關會議記錄。

1. 執行自動化運轉系統之相關專案。 2. 維持工廠內自動化系統之正常運作及改善系統缺點。 3. 進行自動化系統之日常點檢和定期保養 。 4. 負責自動化設備、系統介面之維護及改善。 5. 負責自動化系統各類規範與相關文件之撰寫、修改及操作人員之執照鑑定。 6. 查閱電路圖能力。 7. 在作業現場監控機台與人員的作業狀況。 8. 主管交辦事項。 9. 須配合偶時加班。