Altek Biotechnology_榮晶生物科技股份有限公司

職務內容： 1. 醫療器材開發前設計概念發想及技術可行性評估 2. 醫療器材整機或模組機構規劃，風險分析，設計，開發及驗證 3. 醫療器材先期評估、風險分析、設計、開發、驗證、量產導入之相關文件製作 4. 針對特定工程主題蒐集相關機構知識，進行專業分析 5. 協助產線解決量產中製造及製程中的機構相關問題　

1.客戶管理 ·了解客戶需求和問題 ·與公司内部各部門協作、提供適當的解決方案、提升客户滿意度 ·與Account Operator合作、共同達成營收目標 2. 銷售推廣與執行 ·制定銷售計劃,達成銷售目標 ·推廣公司產品或服務,介紹其優勢和特色 ·確保銷售相關文件、合同準備與簽署 3.客户開發 ·拓展潛在客户、了解需求 ·與內部團隊協作制定方案 4. 報告與記錄 ·定期總結匯報工作進展及業務情況 ·維護和更新客戶資料和銷售記錄 5. 市場調研與分析 ·收集市場訊息,了解行業動態和競爭對手的產品情況,提供市場分析報告 ·根據市場需求,建議產品改進或新產品開發

1.Project schedule planning and control to ensure mass production on schedule. 2.Communication and coordinate with customer/vendors. 3.Manage and wiling to drive cross-functional groups to ensure project completed and success on schedule. 4.Control project from multiple aspects in terms of issue tracking, risk, quality, cost and schedule.

此職務共分為兩種類別，會依照您的專業及興趣討論較適合您的職務 一、自動化電控工程師 1. 自動化機台系統與電控規劃/設計/安裝/測試。 2. 針對產品特定工程與製程進行設計研發及測試。 二、自動化機構工程師 1.執行自動化設備之機構/治具設計研發及測試調校。 2.針對產品特定工程與製程進行設計研發及測試。

1.新產品導入管理 2.跨部門協調與溝通 3.技術評審與問題解決 4.風險評估與管控 5.文件與流程管理 6.供應商與客戶技術支持

1. 自動化機台系統與電控規劃/設計/安裝/測試。 2. 針對產品特定工程與製程進行設計研發及測試。

工作詳細內容Job descriptions： Responsibilities & Authorities: • Provide quality assurance support throughout product development and pilot build phases, ensuring compliance with applicable quality standards and regulations. • Review and approve design-related documentation, including specifications, verification/validation protocols, and reports. • Participate in design transfer activities, ensuring quality requirements are met during transition from development to manufacturing. • Coordinate and manage change control processes, ensuring documentation accuracy and traceability. • Support investigation and resolution of product-related issues, including customer complaints and RMA cases, in accordance with regulatory and client requirements. • Review and approve deviations, CAPAs, risk assessments, and nonconformance reports related to development and pilot production. • Collaborate with cross-functional teams to ensure quality perspectives are integrated into product development decisions. • Conduct gap analysis of existing procedures and support updates to align with current standards (e.g., ISO 13485, ISO 14971). • Assist in supplier evaluation and tool validation activities as needed. • Other duties as assigned to support quality and regulatory compliance.

1. HWQA test for Endoscopy system, blood glucose meter for medical equipment and medical device. (Test item example: Biocompatibility, IPX code, Sterilization, validation, Environment, Shelf life test, Mechanical .., ) 2.Reliability test for medical equipment and medical device. 3.EMC/Safety test for medical equipment and medical device. (Endoscopy system, blood glucose meter... etc.) 4.Medical equipment and medical device test standard review for related to Bio/EMC/Safety/IPx code etc., 5.Bio/EMC/Safety/HWQA test report review 6.EMC/Safety debug for medical equipment and medical device. (Endoscopy system, blood glucose meter.) 7.Layout review and co-work with RD for design review.

1.Familiar with category in EM(Cable, connector), EE 2.Strategic Sourcing to achieve cost, quality and service objectives 3.Supply Chain Base Management and Partnership Development for ensuring the overall Supply Chain performance 4.Cost management from NPI to MP projects 5.Project Management Skill, can-do attitude and co-work with PM/RD/Sales/Buyer teams 6.To formulate contingency plan and substitute programs to ensure material provisioning 7. Able to utilize ERP and related IT tools to fulfill/streamline the business processes

Responsibilities & Authorities: • Lead and manage Product Verification Team for medical devices. • Provide the verification strategy for projects. • Reponsible for and continuously improve Design Verification & Validation planning, execution, and reporting process. • Oversight the testing program cross the sites. • Ensure the products in compliance with industry standards and regulations. • Develop and implement comprehensive testing protocols, analyze test results, and provide detailed reports. • Collaborate with other departments to address quality issues or debug issue. • Communicate with Customers for testing protocol, criteria, and report. • Train and mentor team members. • Have the experience in EMC, Safety, Reliability, debug, and provide the consultancy for problem solution. • Coordinate the resources and planning the outsourcing (3rd party) for Biocompatibility Testing / Sterilization Validation in regulated environment. • Manage the testing labs and plan for lab certification or procedure. • Manage and monitor dept KPI to be achieved and budget planning.

工作詳細內容Job descriptions： Responsibilities & Authorities: 1. 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. 2. Responsible for quality oversight and execution for medical devices during the product lifecycle and the associated Quality System. 3. Work on assigned projects as the QA representative to support the business to ensure the design control process, activities, risk management process and design history files (DHF) are in compliance with internal QMS and regulatory requirements. − Proactively engage with all stakeholders involved with product quality and design transfer. − Responsible for process validation activities incl. tool validation for medical devices. Able to coordinate for tool validation activities with suppliers. − Provide direction for and reviewing and approving deviations, corrective and preventive actions, risk assessments and nonconforming material reports. − Coordinate and oversight the change control process to ensure the process and records are appropriate and accurate. − Handle product complaint/inquiry requests or investigations in accordance to client or regulator’s requirements. 4. Owns and maintain Quality Key Performance Indicators (KPIs) for area of expertise. 5. Other duties as assigned. 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。 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。 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。

職務內容： 1. 對應目前Printer專案需求,此專案核心在於齒輪結構設計,負責齒輪箱傳動系統規劃與設計 2. ID工業設計: 此為輔助功能,除機構設計要求外,以工業設計角度進行提案階段暫行性ID外觀設計.

一、環安（EHS）管理： 1.規劃與執行職業安全衛生計畫、環保管理制度與稽核作業 2.落實政府環安相關法令，編製並申報法定文件（如空污、水污、廢棄物、危害物質等） 3.辦理員工安全教育訓練與消防演練 4.審查承攬商施工安全計畫與現場稽核 5.負責職業災害處理、調查與改善追蹤 6.協助推動 ISO 14001 / ISO 45001 / ESG 等管理系統 二、廠務與設備維運： 1.廠區基礎設施日常巡檢與維護（空調、水電、門禁、照明等） 2.公共設施（空壓、水塔、UPS等）維保與外包商管理 3.協助辦公區/廠區之空間調整、設備安裝與工程驗收 4.水電用量監控與能資源效率改善建議 5.協助災防計畫擬定與緊急應變機制維護

1. 開發新客戶，推廣醫材產品，參與/協助貿易展覽和主要行業相關活動 2. 接待重要外賓、擔任客戶窗口 3. 接洽客戶，保證專案時間進度以及規劃 4. 統整客戶訂單，優化排產 5. 擬定行銷策略、宣傳管理、文案撰寫、製作圖像和影片內容 6. 協調各項跨部門溝通、整合及規劃 7. 協助專案推動與時程控管、對外及各部門之溝通聯繫事宜、文件追蹤、資料彙整 8. 其他主管交辦事項 工作地點：新竹科學園區及台北內湖皆有辦公室(會依您所在地安排合適的辦公室)

1. 合併報表、轉投資彙總、會計師財務報告 2. 稅報、移轉訂價報告及營所稅申報 3. 成本會計、預算編列與分析 4. 主管交辦事項

•新技術與電子零件評估。 •執行調試、測試和驗證產品，以滿足醫療法規和品質標準。 •維護文檔並為醫療產品生命週期管理提供支援。 •協助組裝和產線製程問題。

1.Project schedule planning and control to ensure mass production on schedule. 2.Communication and coordinate with customer/vendors. 3.Manage and wiling to drive cross-functional groups to ensure project completed and success on schedule. 4.Control project from multiple aspects in terms of issue tracking, risk, quality, cost and schedule.

1.協助申請產品階/包裝階料號，完成BOM表建檔作業。 2.協助包材設計變更之工程變更維護發行作業。 3.協助樣品製作、進度追蹤、收樣與承認流程處理。 4.基本2D圖面繪製與簡易修改（如包裝結構、標籤零件圖等）。 5.參與主管交辦事項 6.此職務為約聘職

工作詳細內容Job descriptions： Responsibilities & Authorities: • Provide quality assurance support throughout product development and pilot build phases, ensuring compliance with applicable quality standards and regulations. • Review and approve design-related documentation, including specifications, verification/validation protocols, and reports. • Participate in design transfer activities, ensuring quality requirements are met during transition from development to manufacturing. • Coordinate and manage change control processes, ensuring documentation accuracy and traceability. • Support investigation and resolution of product-related issues, including customer complaints and RMA cases, in accordance with regulatory and client requirements. • Review and approve deviations, CAPAs, risk assessments, and nonconformance reports related to development and pilot production. • Collaborate with cross-functional teams to ensure quality perspectives are integrated into product development decisions. • Conduct gap analysis of existing procedures and support updates to align with current standards (e.g., ISO 13485, ISO 14971). • Assist in supplier evaluation and tool validation activities as needed. • Other duties as assigned to support quality and regulatory compliance. • Location：馬來西亞柔佛州 12, JALAN TEKNOLOGI PERINTIS 1/3,TAMAN TEKNOLOGI NUSAJAYA , 79200 ISKANDAR PUTERI, JOHOR

工作詳細內容Job descriptions： Responsibilities & Authorities: • 支援品質管理系統（QMS）的執行與維護，確保符合 ISO 13485 等相關標準。 • 協助新產品開發與試產階段的品質相關文件建立、審查與維護。 • 協助文件管控作業，包含版本管理、文件追蹤與合規性確認。 • 參與內部品質審查，協助跨部門團隊確保文件完整性與準確性。 • 協助追蹤與管理品質改善事項，如偏差處理、矯正與預防措施（CAPA）、風險評估等。 • 協助稽核與查核準備工作，整理並提供相關品質紀錄與文件。 • 與品保工程師合作，確保品質要求能納入產品開發流程中。 • 其他主管交辦事項，以支援品質與法規遵循目標。