製程工程師
Description
工作內容:
1. 生產數位生物條碼(BMB)系列產品。
2. 產品品管測試、製程管制與確效。
3. 儀器設備保養、管理與生產環境維護。
4. 產品與製程相關文件撰寫與修訂。
5. 其他主管交辦事項,可能包含但不限:例如協助美國原廠進行研發項目可行性評估、製 程優化測試等。
本職務視實際需求,安排ISO13485、ISO 14971、醫療器材法規等外部訓練課程。
Job Responsibilities:
1. Produce Barcode Magnetic Beads (BMB) series products.
2. Perform quality control testing, process control, and process validation for BMB products.
3. Maintain the equipment/instrument and production environment.
4. Draft and revise the product and process-related quality documents.
5. Other tasks assigned by the manager, which may include but are not limited to: assisting the parent company in conducting feasibility studies for R&D projects, process optimization tests, etc.
Based on actual needs, we will arrange external training courses such as ISO13485, ISO 14971, and medical device regulations for this position.