「品質專案管理 QPM (Quality Project Management)」的相似工作

1、製造流程中的品質管控、異常處理及相關對策追蹤 2、確保流程有效性及符合性, 在內外稽核活動中防止問題發生 3、確保新產品轉量產後的品質管控能力, 建立有效文件, 執行量產中測試 4、參與品質中心各項改善活動 5、需出差支援其他廠區品質活動

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.目標導向,重視專案進展流程設計,展開可監控的計畫。 2.海外整合資源,分解工作,有效執行資源配置與監督作業。 3.進行有效的風險管理,隨時處理突發情況,完成公司交付任務。 4.協助開發團隊完成客戶所定義的目標與時間。 5.需要大量跨部門溝通,串起不同部門資源,發揮組織綜效。

【職務內容】 1.現有系統及流程理解。 2.專案立案、執行、追蹤及管理。 3.需求訪談：引導客戶、進行需求分析、需求訪談記錄與計劃書撰寫。 4.專案溝通：執行部門與專案成員間溝通與討論。 5.專案管理：召開各階段專案會議與時程品質管理。 6.文件撰寫：需求書、計畫書、驗收文件、操作手冊等文件撰寫及蒐集。 7.協助專案測試與各專案項目追蹤檢討。 【職務需求】 - 一年以上「軟體專案管理」執行經驗(請分享案例) - 負責任、主動積極、願意學習新的事物 --------------------------------- ●完整的教育訓練 ●透明的升遷制度 ●良好的辦公氛圍 ●豐厚的獎金及福利

1、製程巡檢 2、成品量測 3、外觀檢驗 4、檢驗報表維護 5、異常通報及初步處置 6、主管交辦事項

1.協助ISO45001、ISO50001、ISO14001系統之維持。 2.審核供應商提供之綠色環保文件，是否符合公司及法規要求。 3.客戶產品綠色環保資料彙整/回覆並上傳至平台。

1. 製程異常分析。 2. 品保站別支援。 3. 例行品保報表。 4. 儀器校正。 5. 其他主管交辦事項。 ☆ 具ISO9001/ISO14001/IATF16949證照或經驗者尤佳。 ☆ 具8D報告分析、CCD、AOI相關經驗者尤佳。 ☆ 具英文能力及相關實務經驗者尤佳。 ☆ 振專採「團隊合作教學領導」歡迎無相關經驗及社會新鮮人應聘。 ☆ 工作穩定具發展性：歡迎加入我們振專的專業團隊！

SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland since late 2018, with sites in Sweden, Taiwan, and the Unites States. 【Job Overview】 The Supplier QA Engineer is responsible for • To drive supplier quality performance, including new product development and product quality improvement • Overseeing supplier quality and establishing quality control objectives • Ensuring the supplier fulfill regulatory and SHL’s requirements • Performing quality system audits and development good partnership with suppliers 【Main Responsibilities】 • Ability to manage the quality of products and services provided by suppliers, ensuring compliance with company standards and requirements. Independently conduct investigations on abnormalities, analyze potential process risks, identify root causes, and drive improvements to continuously enhance supplier quality performance. • Experience in planning and executing supplier evaluations and audits, including document reviews and on-site inspections. Coordinate and support second-party and third-party certification audits. Evaluate supplier responses to deficiencies and lead supplier quality improvement initiatives. • Familiarity with quality management systems and relevant standards (e.g., SOPs, GMP). Capable of developing and maintaining quality documents and training programs. Provide quality and GxP training to internal teams and suppliers to ensure audit readiness. • Skilled in data analysis to drive continuous improvement projects aligned with departmental and company goals. • Strong communication and coordination skills to effectively collaborate with cross-functional teams and suppliers, resolve quality issues, and report quality status and audit findings to senior management. • 具備管理供應商產品及服務品質的能力，確保其符合公司標準與要求。能獨立展開異常調查，分析製程風險，找出根本原因並推動改善，促使供應商持續提升品質表現。 • 能規劃與執行供應商評估及審核，包括文件審查、現場稽核，以及協助安排第二方與第三方認證稽核。能評估供應商缺失回應並帶領品質改善計劃。 • 熟悉品質管理系統及相關標準（如SOP、GMP等），能制定及維護品質文件與培訓計劃，並提供內部與供應商的品質及GxP培訓，確保稽核準備度。 • 擅長運用數據分析推動持續改善計劃，以達成部門及公司目標。 • 具備良好的跨部門及供應商溝通協調能力，能有效解決品質問題，並能向高層管理者報告品質狀況與稽核結果。 【Qualification】 • A bachelor's degree in engineering, manufacturing, technology-related fields or other science-related fields is required. • At least three years of experience in quality assurance, preferably in the medical device, biopharmaceutical, or other regulated industries. • Familiarity with 21 CFR part 820, ISO 13485, and cGMP is a plus. • Internal audit training in ISO 13485 / ISO 9001 or equivalent is a plus. • Experience managing external quality audits is a plus. • Familiarity with quality tools, audit techniques, and problem-solving skills is a plus. • Ability to collaborate well within a cross-departmental team and independently manage workload. • Good interpersonal, written and verbal communication skills in both English and Chinese. • 具備工程、製造、技術相關或其他理工科相關領域的學士學位。 • 至少三年以上品質保證相關經驗，醫療器材、生物製藥或其他受規管產業經驗者優先。 • 熟悉21 CFR Part 820、ISO 13485及cGMP者佳。 • 具備ISO 13485 / ISO 9001內部稽核培訓經驗者優先。 • 具管理外部品質稽核經驗者佳。 • 熟悉品質工具、稽核技巧及問題解決能力者優先。 • 能良好協作跨部門團隊，並具備獨立管理工作負荷的能力。 • 具備良好的人際關係、中文及英文書面及口頭溝通能力。

1.執行產品各開發階段的驗證測試。 2.進行環境、耐受性及信賴性測試，確保產品可靠性。 3.擬定並執行測試計畫，撰寫測試報告。 4.追蹤測試問題，與電子工程師協同改善並驗證修正結果。 5.與電子工程師及品保部門合作，優化測試流程。 6.協助主管交辦之其他相關事項。

職務影響力 致力於提升 Gogoro 各項產品從零部件到整體系統的機構可靠度，針對產品硬體機械擬定測試計畫、執行功能性、耐久性、可靠性、安全性等測試與驗證，經由設計審查與驗證結果提出改善建議並發現潛在風險，以維持並持續優化產品品質。 職務內容 1. 理解產品設計目的與中英文元件規格，熟悉設計目標與測試需求。 2. 規劃能鑑別與解決關鍵設計問題的測試項目與策略，提供具體改善建議。 3. 執行功能性、耐久性、可靠性與安全性測試，撰寫測試報告並追蹤問題解決進度。 4. 規劃並管理測試時程，協調資源配置，提升測試流程效率。 5. 與專案團隊、工程與品保部門密切合作，優化測試流程與策略。 6. 開發並維護測試所需之治具與設備，提升測試自動化與準確性。 7. 以使用者角度提出觀點，提供關鍵品質判斷與風險建議，協助專案做出更佳決策。 需求條件 1. 具備 3 年以上機構相關測試、驗證、品保或設計等相關經驗。 2. 對測試流程與方法具高度敏感度，能發現並分析產品潛在風險。 3. 邏輯思維清晰，細心負責，能勝任重複性作業與問題追蹤。 4. 具備中等以上英文閱讀與書寫能力，可理解英文規格書並完成報告撰寫。 5. 熟悉 Google Workspace 工具（Docs、Sheets、Slides 等）之操作與協作。 6. 熟悉任一 3D 繪圖軟體（如 Pro/E、AutoCAD 等），未來將需使用 OSD，具工具轉換能力者佳。 加分條件 1. 熟悉 OSD 操作流程與介面者優先考慮。 2. 具備自動化測試設備或治具開發經驗者。 3. 具備跨部門協作或新產品導入（NPI）相關經驗者。

Job descriptions: 1. Market Research: Identify new markets, trends, and competitors to uncover business opportunities. 2. Client Acquisition & Management: Build relationships with new clients while maintaining strong ties with existing ones. 3. Strategic Planning: Develop growth strategies to expand the business and diversify products. 4. Team Collaboration: Work with product, sales, and marketing teams to meet client needs and align goals. 5. Negotiation & Deal Closure: Lead client discussions to finalize agreements beneficial to both parties. 6. Performance Tracking: Monitor and evaluate the success of business initiatives and adjust as needed. Key Qualifications: 1. Education: Bachelor’s degree in Business, Marketing, or a related field (Master’s preferred). 2. Experience: Prior success in business development or sales, especially in tech or manufacturing. 3. Skills: Strong market analysis and strategic thinking. Effective communication and negotiation abilities. Teamwork and relationship-building expertise. 4. Industry Knowledge: Familiarity with the computer peripherals market is a plus.

1)負責公司品質紀錄與品質系統文件的歸檔與管理。 2)協助ISO文件變更的發行。 3)協助內部稽核執行與文件彙整。 4)協助圖面、EC變更文件歸檔。 5)協助製作品質會議記錄。 6)協助客戶端文件上傳與整理。 7)其他主管交辦事項。 加分條件 1. 具備ISO 13485 or IATF 16949 DCC實務經驗。 2. 具備ezGPM平台系統操作經驗。 3. 文件管理與資料夾管理細心有條理且具邏輯。

1.負責廠內外品質異常處理 2.製作各項品質報表報告，制定品質相關規格與管制計畫 3.負責客訴調查與改善、客戶製程稽核與拜訪相關事宜 4.客戶關係維持與發展 5.協調與整合各部門品質提升專案 6.新機種導入與品質管控 7.伺服器(L10,L11)生產經驗尤佳 PS. 歡迎社會新鮮人加入

1.協助ISO17025實驗式運作。 2.執行各製程別與委託樣品檢驗、整理更新檢驗數據。 3.量測儀器維護、定期保養、預防保養執行。 4.量測儀器點檢、實驗室耗材與備品管理。 5.執行MSA量測系統分析。

1. 廠內/ 市場 車用品質管理 跟蹤處理 (8D report), 報告給客戶。 2. 改善產品信賴度、可靠性、品質，進而全面提升產品品質。 3. IATF16949體制之推行、製品IPQC及OQC管理。 4. 規劃品質系統相關之教育訓練 (年度訓練規劃)。 5. 主導內部稽核活動及外部認證，監督及管理。 6. 檢驗標準之制定。 7. 負責文件管理之建立與維護。相關統計圖表製作。 8. KPI規劃與管理。

1、主動負責產品專案之RFQ 詢價報價作業 2、主動負責產品專案之試產及量產的資材範疇作業 3、管理RFQ & NPI 及MP 的產品價格毛利盈虧 4、對接客戶採購資材窗口 5、串接梳理企業內部各部門窗口 6、管理價格，交期，物料管控...等各項指標 7、其他臨時交辦事項

Company Overview SHL Medical is a world-leading solution provider in the design, development and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland since late 2018. Taiwan has been SHL’s starting ground in our bid for global mobility in the fields of drug delivery and medical technology. Our ambitious people who come from various cultures share the same aspiration – ensuring the right drug device for the delivery of modern precision medicine. Job Overview 此職位主要負責製造部門-MFMG的品質控管, 與公司品質部門合作, 進行零件生產品質的提升與問題調查, 整體提升MFMG的生產品質與人員品質意識. Main Responsibilities 1. 負責零件製造部門(MFMG)的品質政策執行 2. 品質文件 3. 品質系統 4. 品質管理與事件調查 5. 生產零件問題回饋即時處理 6. 品質會議 7. 客戶稽核業務 8. 提升零件品質與人員品質意識 9. 其餘品質相關 Required Skills & Qualifications • 具產品生產品質管控經驗: 一年以上 • 具產線相關品質改善經驗 : 一年以上 • 具品質系統能力 • 初級數據分析能力 • 具射出經驗者為佳 • 具語言能力: 多益約500分以上之能力

1. 工廠生產SOP規範建立 2. 生產巡檢稽核 3. 新商品試產與導入 4. 生產效率提升 5. 落實完成主管交辦事項 《休假》排班制，月休9~10天 *另有交通津貼、免費供午膳 ●員工福利： 保險-勞、健保、勞退提撥、團體保險 禮券-春節/端午/中秋禮劵、勞動節禮劵、生日禮劵禮劵 獎金-年節獎金 補助-婚喪喜慶、生育補助 其他-員工生日假、部門旅遊聚餐、春酒、免費健康檢查、免費員工制服

1. 機台檢測及報告製作 2. 依照文件規範執行IQC, IPQC , OQC檢驗 3. 檢驗流程改善及標準作業程序修訂 4. 異常事件追蹤處理 5. 機台異常狀況處理 6. 檢驗異常狀況處理與回報 7. 報告撰寫與整理 8. 文件檢查及歸檔 9. 主管交辦事項

1.ISO內控文件、研發圖面及資料歸檔 2.PLM、SAP、EC、BOM系統流程控管 3.部門文書事務處理 4.主管交辦事項