Altek Biotechnology_榮晶生物科技股份有限公司
【QA】品保工程師/資深工程師Quality Assurance Engineer/Senior Engineer(台北/新竹)
9/18 更新
Array
英語 条件要件
フルタイム
上級
英語 条件要件給与 & 勤務地
待遇面談
（給与条件は常に4万台湾ドル以上）
台北市內湖區
条件要件
言語要件
英語
聽/精通、說/精通、讀/精通、寫/精通
職務経験
3年以上
職務内容
工作詳細內容Job descriptions：
QA Engineer/Senior Engineer: (1名)
Responsibilities & Authorities:
．Responsible for quality oversight and execution and prepare inspection criteria and standards for the assigned projects throughout the product lifecycle and the associated Quality System. Provide QA Approvals/Perspectives as needed.
．Proactively engage with all stakeholders involved with product quality and design transfer.
．Coordinate and oversight the change control process to ensure the process and records are appropriate and accurate.
．Responsible for customer complaint, product return/repair (RMA) and investigations in accordance to client or regulator’s requirements.
．Provide direction for and reviewing and approving deviations, corrective and preventive actions, risk assessments and nonconforming material reports.
．Able to coordinate for tool validation activities and supplier evaluation.
．Able to support process improvements by gap analysis of existing SOPs or processes against up-to-date standards and regulations and updates accordingly.
．Other duties as assigned.
工作詳細內容Job descriptions：
Responsibilities & Authorities:
Reponsible for Hazardous Substances Management System including:
Periodically update the applicable regulations (RoHS/REACH/SVHC/POPs/ED/PFAS/BPA/Latex/EU - CMR/Cal Prop 65) for medical devices.
Capable of conducting risk assessment and evaluating the impact of new or revised regulations/standards.
Collect and obtain the declaration, report, or evidence from Suppliers for compliance.
Establish and manage the hazardous Substance Database.
Complete the hazardous substances information for components and products approval.
負責有害物質管理系統，包括定期更新醫療器材適用之法規標準，具備針對新制定或更新之法規與標準之風險分析與影響評估，蒐集供應商端的符合性宣告/報告/或相當證據證明符合性，建立與維持有害物質資料庫。
Responsible for process validation activities incl. tool validation for medical devices. Able to coordinate for tool validation activities with suppliers.
負責確校活動審查，例如模具/製程確校，輔導與教育外包供應商，符合內部規範。
Provide direction for and reviewing and approving deviations, corrective and preventive actions, risk assessments and nonconforming material reports.
Able to support quality assurance activities for assigned projects.
Other duties as assigned.
負責相關事務之異常偏差、矯正行動與風險評估等。支援所指配專案的品質活動或其他臨時指派事項。
応募者数
1~1人
学歴要件
大學(學院)以上
勤務時間
日班
休暇制度
週休二日
職種カテゴリ
QA / QC Engineer
ISO / Quality Assurance Staff
QA / QC Supervisor
新竹市
醫療器材製造業
榮晶生物科技於2014年、由華晶科醫療事業部正式獨立為榮晶生物科技股份有限公司，承襲華晶科數位影像技術，將其應用於生物科技醫療產品，並轉型為電子醫療產品設計與製造領域的領導者。目前所生產的血糖機及拋棄式內視鏡的出貨量佈及全球，品質系統穩定可靠，深受國際藥廠的信賴。這也為公司在電子醫療產品領域踏奠定了扎實的基礎。在精密製造技術能力的基礎上，我們將致力於創新產品的開發，以提供更具競爭力、符合國際醫療器材潮流的生醫產品。
獲獎實績
2019年 「第六屆經濟部國家產業創新獎」
