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品保人員
1. 品質管理與文件維護建立、維護 ISO 13485／QMS 品質管理系統文件。撰寫、審核 SOP、檢驗規範與品質記錄文件，管理文件版控。監督製程品質、例行檢查與文件稽核，追蹤改善項目。 2. 保存資料並且定期更新以備日後審核 3. 法規遵循與稽核協作協助準備 CFDA／TFDA／FDA／ISO 稽核與認證文件。配合內外部稽核（ISO13485、客戶審查、供應商稽核）。追蹤醫療器材法規變動並更新品質系統要求。 4.…
【業務處】專案經理
我們正在尋找一位具備熱忱與專業的 專案經理，加入我們的醫療器材開發團隊。若您對創新醫療技術充滿興趣，並具備良好的專案管理能力，歡迎加入我們，一起推動健康科技的進步！ ________________________________________ ｜工作內容｜ 規劃並分配專案資源，確保進度與品質達標 擬定專案時程，並與客戶、內部團隊共同確認與追蹤 主導專案啟動、設計審查、進度追蹤等會議 有效率追蹤行動項目與進度，讓每一步都精準到位…
【PM】Product Manager_AMED
Position Overview As a Product Manager for our core AI-based Software as a Medical Device (SaMD) portfolio, you will own the product lifecycle from initial concept to market launch (0 to 1). You will bridge the gap…
品質系統管理師
1. 維持醫材品質管理系統的有效性(ISO 13485/TFDA QMS)。 2. 因應產品海外上市符合性需求, 對各區域醫材品質管理系統的特定要求(例如QMSR, EU MDR, KGMP…)進行差異分析及導入，執行廠內品質系統文件備置及流程優化。 3. 新廠區品質系統認證的規劃及執行。 4. 客戶/驗證機構/主管機關等外部稽核應對窗口。 5. 遠程稽核文件備置。 6. 其他主管交辦事項。 【其他條件】 1.…
品保_DQA設計品質保證副工程師(土城廠/無經驗可)
*協助醫療急救器材產品開發設計驗證作業， 並依循 ISO 13485 品質管理系統要求， 確保新產品開發流程符合品質與法規標準，包含： 1. 製作SIP及品保相關文件 2. 執行工件量測與報告製作 3. 量具卡製作及歸檔 4. 執行主管交辦事項
醫療 AI 產品專案管理師（PM / Senior PM）
我們是一支專注於 AI 醫療軟體與臨床決策支援產品 的團隊，產品以真正進入醫院、完成臨床驗證與醫療器材查驗登記為目標。 這個職位會參與醫療 AI 產品的完整生命週期，從臨床需求、產品規劃、AI / Software 開發協作，到臨床研究、醫材查登與醫院落地。 你會站在 臨床 × 產品 × AI × 軟體 × 醫材法規 之間，與醫師、醫療人員、工程師及合作夥伴共同推動產品落地。…
生產技術工程師
LightMed 是自有品牌的眼科／牙科醫療雷射製造商，產品外銷全球多達80餘國家。 參與人員將負責雷射設備從試產到量產的製程建立與品質穩定，並參與國際認證送測，是產品上市前的關鍵角色。 工作內容 1. 建立與優化雷射設備的組裝、測試製程及 SOP／WI（依 ISO 13485 體系） 2. 產線異常分析與改善：[電路板／光路／機構] 問題的除錯、根因分析、矯正預防措施（CAPA） 3.…
【嘉義廠】品檢員(進料檢驗/製程巡檢)
進料檢驗（IQC） 1.負責原材料、零組件及包裝材料之進料檢驗作業。 2.依據檢驗規範、圖面及AQL抽樣標準進行檢驗。 3.確認供應商來料之尺寸、外觀、功能及文件符合規格。 4.填寫與維護進料檢驗報告與檢驗紀錄。 5.不合格品判定與回報，並協助供應商異常處理與追蹤。 6.協助供應商品質改善及異常分析。 製程巡檢（IPQC） 1.負責生產線之製程品質巡檢與監控。 2.依製程檢驗標準進行首件檢驗與定時巡檢。 3.確認製程作業符合…
Automation & Controls Engineer - ON SITE ONLY
Job Title: Automation and Controls Engineer Educational requirements: 2–4-year degree in engineering, automation, mechatronics, or a related technical discipline preferred; Other technical degree with equivalent…
Senior Electrical Engineer - Medical Device #1899
About ECI ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest…
Supplier QA Engineer III
Recruiter: Francisco Munoz Munoz Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At our company, we value diversity and believe it is our greatest strength. We are committed…
Senior Industrial Engineer
The Senior Industrial Engineer actively contributes to manufacturing process design, hands-on ERP manufacturing-data accuracy, and QMS-compliant process documentation for hearing aid and related medical-device…
Software Verification Manager, Medical Software | REMOTE
Leads software verification and testing for regulated medical software products at Sonova: managing test engineers/SDETs, defining verification strategy, ensuring traceability and controlled quality documentation, and supporting audits and regulatory submissions. Centers on test automation, risk-based testing, and medical device standards like IEC 62304 and ISO 14971.
Director, Industrial Engineering
As the Industrial Engineering Director, you will lead manufacturing process design, ERP data integrity, and continuous improvement for hearing aid (or related medical device) manufacturing operations. This role bridges…
Specialist I, Regulatory Affairs
Valencia, CA (Onsite - Hybrid) International Regulatory Affairs Specialist – Middle East & North Africa (MENA) Advanced Bionics is seeking an International Regulatory Affairs Specialist to support regulatory strategies…
Senior Engineer, Design Assurance
Ensures compliance with medical device regulations (e.g., FDA, EU MDR) for cochlear implant software/hardware design, leading testing, risk analysis, and cross-functional teams to meet safety and quality standards.
Supplier Quality Engineer - Mechanics
Who we are You enjoy creating and innovating. You never stop striving for better. You take responsibility and you get results. You love being part of a team. Above all, you want your work to matter: Welcome to our…
Supplier Quality Engineer - Electronics
Who we are You enjoy creating and innovating. You never stop striving for better. You take responsibility and you get results. You love being part of a team. Above all, you want your work to matter: Welcome to our…
Sr. Director of Quality
Nextek, Inc. is a niche market, technology-driven Electronics Manufacturing Services (EMS) company, founded in 1995. We offer precision electronic assembly and engineering services to customers with needs-driven,…