「智慧製造_QMS品質管理系統_導入顧問(竹北/台中)」的相似工作

This vacancy is open for talent pool collection. We will contact you if we have proper vacancies that fit with your profile. Job Mission Represent manufacturing and act as gatekeeper from manufacturing to D&E function Add value in overall manufacturing processes such as forming, machining, joining, and assembling Job Description Contribute to the solution of faults and takes the necessary initiatives and practical decisions to ensure zero repeat Identify gaps and drive assigned process improvement projects and successful delivery Initiate and drive new procedure changes and projects Develop and maintain networks across several functional stakeholders Prioritize works and projects based on business situation Transfer knowledge and train colleagues on existing and newly introduced products Education Master degree in technical domain (e.g. electrical engineering, mechanical engineering, mechatronics) Experience 3-5 years working experience in design engineering Personal skills Show responsibility for the result of work Show proactive attitude and willing to take initiative Drive for continuous improvement Able to think outside of standard processes Able to work independently Able to co-work with different functional stakeholders Able to demonstrate leadership skills Able to work in a multi-disciplinary team within a high tech(proto) environment Able to think and act within general policies across department levels Diversity and inclusion ASML is an Equal Opportunity Employer that values and respects the importance of a diverse and inclusive workforce. It is the policy of the company to recruit, hire, train and promote persons in all job titles without regard to race, color, religion, sex, age, national origin, veteran status, disability, sexual orientation, or gender identity. We recognize that diversity and inclusion is a driving force in the success of our company. Need to know more about applying for a job at ASML? Read our frequently asked questions.

1負責制定、實施和維護ISO 13485品質系統，確保產品或服務的品質符合公司和客戶的要求。 2協同品質團隊成員，利用品質管理相關的工具和方法，例如FMEA、8D報告、PDCA等等，分析及發掘現有或潛在問題。 3管理品質系統改善項目，與內部各部門和外部供應商、客戶等進行溝通和內外部稽核協調，確保品質管理的有效實施和持續改進。 4負責品質系統的評估和分析，提出改善建議和行動計劃。 5準備和維護相關品質文件，例如品質手冊、程序、工作指導書等等。

1.ISO 9001品質系統地推行與管理維護。 2.協助產出相關文件，確保品質系統實施有效性。 3.主導品質系統內部稽核與第三方作驗證。 4.執行儀器內部與外部校宴。 5.文件管制作業 6.設備安規改善與執行 7.推動持續改善 8.推薦ISO 27001推行與第三方驗證 9.主管交辦事項

1. ISO品質系統導入及運行。 2. 文件管理與審查 3. 安排主導內/外部稽核及稽核缺失處理以確保品質系統實施的有效性。 4. 負責品質教育訓練計劃之擬定與執行。 5. 公司系統流程

1. 處理客訴、退貨、CAR，並追蹤改善成效。 2. 客戶應對及回覆客戶問題（包含書面回覆與會議簡報）。 3. 撰寫 CAR/8D 報告，提供完整的問題分析與改善方案。 4. 參與內外部稽核及品質檢討會議，提出品質改善建議。 5. 支援其他品保任務（如文件維護、品質教育訓練、品管相關工作等）。 6. 跨部門溝通，協調製造、工程、業務等部門，推動品質改善專案。 7.完成主管交辦之其他任務，確保部門目標達成。

* 維護與更新 ISO 9001 / TL9000 品質管理系統相關文件 * 規劃與修訂品質管理制度，執行文件控管、稽核流程與問題解決流程，並確保制度有效落實 * 支援外部稽核作業，包括客戶稽核及第三方認證機構之年度審查 * 執行內部稽核，包含稽核計畫安排、現場審查與後續矯正／預防措施追蹤 * 規劃並執行品質教育訓練，提升全體員工之品質意識與專業技能

主要負責主管機關相關事務 職務內容： 藥物開發臨床試驗之準備 藥物臨床試驗前報告之確認 藥物/醫材品質系統管控 藥物/醫材查登文件準備

1.品質稽核與流程優化 協助或主導總部現場稽核、品質稽核及審查(ISO 9001、IATF 16949、ANSI/ESD S20.20、ISO 13485 )，並且定期檢視並改善內外部品質系統及標準作業程序（SOP）以及優化NPI客戶品質需求文件。 2. 客戶品質對應與異常處理改善 主導重大客訴案件之調查、根本原因分析（RCA），推動內部改善對策（如製程優化、檢驗強化），編寫並提交 8D / 5Why / Fishbone 等問題分析報告，必要時需出差支援海外廠相關品質議題。 3. 品質目標監控與提升 制定並監控課內各項指標，分析達成進度並推動相關改善行動，提升部門績效管理。 4. 推動 ESG 專案 主導公司 ESG 相關工作，包括產品碳足跡的盤查、碳排放數據的收集與分析、碳減排目標的設定與落實，支持公司永續發展戰略。 5. 主管交辦事項的執行 協助完成主管交付的各項工作，並靈活應對部門其他臨時需求。

1.維護 ISO9001 / ISO14001 / ISO45001等相關品質系統。 2.品質系統內外部稽核。 3.相關規範符合客戶需求文件的審核。 4. 負責內部文件更新、發行、審核與跟催等作業。 5. 分類、審核、補正、建立SOP各部門文件資料，並輸入建檔。負責一般文件處理和檔案管理工作。 6. 責任心、樂觀積極、可獨立作業(具有公司ISO文管及ISO相關稽核文件經驗佳)。

1.廠級相關Project, Lead導入與執行 2.配合公司相關品質政策活動之稽核 3.品質異常或客戶回饋問題之改善成效確認 4.執行製程稽核與品管檢驗工作 5.各種品質報表之填寫及稽核 6.ISO相關品質系統維護與執行 7.品質相關活動推展與品質改善活動專案執行 8.品管作業規範執行與稽核

Introduction to the job Do you like challenges and do you want to work in a fast pacing supply chain environment to support some of the biggest semiconductor companies worldwide? Are you familiar with Logistics Operations and like to managing urgent demands on a daily basis?  If this sounds like you and if you have a strong customer oriented mindset, here is your mission. Role and responsibilities For our Global Operations Center in Taiwan we are searching for Supply Chain Professionals. You fulfill the demand of our customers for spare parts and tools for their maintenance activities on some of the most complex machines in the right quantity and at the right time & cost. Time is of the essence to ensure a seamless production of our customers without interruptions on our machines. -Handling of urgent material requests from worldwide customers in a rolling 24/7 shift system with the right customer focus, while meeting all milestones related to communication and execution -Monitoring of worldwide shipments  -Ability to resolve complex issues and drive improvements to further optimize processes -Ability to support escalations and provide communication proposals for review -Constructive and reliable communication with worldwide stakeholders from all departments within ASML -This position requires shift work. Education and Experience Bachelor's Degree in related subject i.e. Supply Chain Management, Information Science, Engineering etc. preferred -Minimum 1 year of relevant experience in an international company, semiconductor industry is preferred -A tactical thinker with strong interpersonal and communication skills -Analytical thinking and ability to organize and prioritize workload Skills Working at the cutting edge of tech, you’ll always have new challenges and new problems to solve – and working together is the only way to do that. You won’t work in a silo. Instead, you’ll be part of a creative, dynamic work environment where you’ll collaborate with supportive colleagues.  There is always space for creative and unique points of view. You’ll have the flexibility and trust to choose how best to tackle tasks and solve problems. To thrive in this job, you’ll need the following skills: -Stress-resistant; act under high pressure -Flexible; willing to go the extra mile for the customer -Excellent professional communication in English, written and oral -Drive for results; does not stop until solution has been found, even when obstacles arise -Team player -Change management competencies -Convincing, pro-active and “can do” mentality -Cultural awareness -Experience with ERP system(s), SAP R/3 knowledge preferred -Ability to prioritize Diversity and inclusion ASML is an Equal Opportunity Employer that values and respects the importance of a diverse and inclusive workforce. It is the policy of the company to recruit, hire, train and promote persons in all job titles without regard to race, color, religion, sex, age, national origin, veteran status, disability, sexual orientation, or gender identity. We recognize that diversity and inclusion is a driving force in the success of our company. Need to know more about applying for a job at ASML? Read our frequently asked questions.

【工作樣貌】 作為品質管理專員，您將負責維持公司品質管理系統的運作，確保符合IATF16949和ISO9001等國際標準，並協助內外部稽核與供應商管理，持續提升整體品質水平。 ●維持IATF16949 / ISO9001 認證，確保品質系統符合國際標準 ●協助客戶稽核的事前準備，並跟進稽核後各部門的改善措施 ●執行內部稽核，包括6S管理、系統與製程稽核，確保內部流程標準化 ●進行供應商稽核，保障供應鏈品質 ●管理ESD防護措施，確保產品不受靜電損害 ●負責文件與記錄的管理，維護準確性與可追溯性 【團隊成員】 協作性強的團隊氛圍，確保每個成員都能相互支持 彈性工作時間，提升您的生活與工作平衡 【職缺條件】 ●熟悉IATF16949 / ISO9001等國際品質標準 ●有稽核經驗，具備有效的問題解決與協調能力 ●了解6S管理及ESD防護措施 ●熟練的文件與記錄管理能力，細心負責

• 半導體 前端工藝相關經驗 （CMP） • 定期與原廠審查 OEM 產品品質。(OEM 管理） • 協助 OEM 與原廠進行良好的溝通。 • 調查質量問題並實施改進措施。。 • 管理 QMS 相關文件。

1.負責監督、改善和統籌本單位所有工作事務 2.主導並建立良好品質管制 3.建立廠商料件規範及出貨品質規範 4.提升單位組織與QC教育訓練 5.熟悉ISO9001系統 6.具有五年QC經驗，且具主管職經驗者佳 7.具半導體經驗者尤佳 8.完成主管交辦事項

百進生技品保專員之主要工作，是在基於公司的展望、任務、品質政策與品質目標，負責維護、管理、改進公司內部品質系統，並執行包含設備、製程、測試方法、電腦軟體與系統的確效與驗證。 [工作內容] * 品質文件的建立、查核、管理與建檔。 * 確保設施中的所有設備，能按照使用目的與使用步驟，適當地安裝與操作，使相關流程可信賴，並具有良好再現性，達到品質規範的標準。 * 供應商品質管理、輔導、稽核與評鑑、管制與改善、品質異常處理及改善對策確認。 * ERP系統建置及導入品質系統。 * 規劃品質系統相關教育訓練。 * 收集與分析數據，製作儀器與設備等之確校報告。 * 支援品質系統的內外部品質審查、變因管控、風險管控、客訴、不符規範產品、矯正計畫、預防計畫，與電子品管系統 (eQMS) 等。 * 其他主管交辦之事務。

如欲投遞履歷,請上Amkor官網 https://careers.amkor.com.tw/ 1.客戶系統/Qual/Annaul 稽核準備及整合 (1) Communicate & feedback with customer for final schedule/agenda (2) Audit topic assign owner & agenda review 2.客戶稽核報告回覆 3.客戶checklist 彙整 4.客戶process audit 準備及整合 5.OQS品質系統稽核 (Cross site/factory) 6.Quality system improvement project

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。

1.檢查、測試量材料、產品、裝置，使之符合規格 2.品質系統推行，並進行系統的稽核，以確保品質系統實施的有效性 3.ISO、文件管制相關作業 4.主管交辦事項

DCC 主要工作項目: 1.文件管理系統維護、管理及優化。 2.公司文件表單編碼、審核、發行、管理及維護。 3.材料承認及SOP分發、管理及回收作業。 4.配合公司內外部品質稽核及認證作業 ESG主要工作項目： 1.ESG品保內部資料收集。 2.配合ESG相關查證作業及永續平台問券回覆。 3.產品碳足跡盤查資料收集。 內部稽核 (Internal Audit) 工作事項: 1.稽核計畫 (Audit Planning)：根據標準要求、管理系統的狀態、上次稽核結果、變更事項等，制定年度或階段性的稽核計畫 2.現場稽核 (On-site Audit)：文件與紀錄查閱： 檢查程序是否符合標準，並審閱相關紀錄，如工單、檢驗報告、校正紀錄等 3.稽核報告與會議 (Audit Report \& Meeting)：稽核報告撰寫： 撰寫正式的稽核報告，內容包含稽核範圍、稽核員、受稽核部門、發現的所有不符合項、觀察項和優點 4.不符合項追蹤 (Nonconformity Follow-up)：矯正措施確認\&有效性驗證 外部稽核 (External Audit) 工作事項: 1.稽核前準備：稽核計畫確認： 組織與外部稽核員溝通，確認稽核目的、範圍、日期、時間表 2.文件準備： 組織需準備所有相關文件、紀錄和資料，並指定對應的陪同人員進行稽核 3.不符合項處理與追蹤:矯正措施提交&稽核員審核

1. 管理系統維護:資訊安全管理系統、有害物質流程管理系統 (具管理系統經驗者佳) 2. 負責外部驗證稽核與內部管理系統稽核 3. 持續改善活動推展 4. 報告彙整