「Quality Engineer(Location:Taoyuan)」的相似工作

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Summary The Senior Quality Assurance Engineer serves as the primary Quality Assurance leader for partner factory management and is responsible for products from multiple sources. He/she participates in the new product development process, ensures that purchased products meet specifications and reliability requirements, and is responsible for customer complaint handling and post-FA activities. In addition, the Senior Quality Assurance Engineer is responsible for leading customer-oriented audit activities at partner factories. The Senior Quality Assurance Engineer works independently and, after initial training, is responsible for learning, understanding, documenting and communicating all Quality Assurance policies, procedures and processes. Work Content: • Interface with partnership factories for all quality, reliability and process issues. • Act as Quality representative in dealing with customer complaint handling and service activities. • Work with partnership factories to analyze customer complaints and returned materials to identify cause of failure. And then drive factory to initiate and implement corrective and preventive action which conforms to Bourns’ CAR process with timely manner. • Access SPC data and production record periodically to work with partnership factories to drive Continuous Improvement in process. • Conduct regular partnership factories on site audit with finding issues tracking. • Take lead in customer-oriented audits in partnership factories with finding issues tracking. • Work within Bourns to conduct assessment while partnership factory development. • Serve as Quality representative in material review board activities and coordinates Quality Control requirements as appropriate. • Involve in new product development process with Engineering team and partnership factory. #品保工程師 #品質技術師 #品質管理 #Quality Assurance #Supplier Quality

主要職責 : 1) Assist in managing the progress of SQMS-SQM project implementation. 2) Troubleshooting system problems and coordinating with various plant users to propose applicable solutions to improve the efficiency of the existing system. 3) Developing and planning for a new quality management system to realize and improve the SQM quality management system. 4) Lead quality activities among factories: quality process cross auditing and improvement, various workshop activities, and dynamic support for each factory. 5) Integration of cross-departmental system resources, planning and unification of workflow.

1.制作並更新品質標準規範 2.品質異常處理與改善 3.OQC檢驗與產品評估 4.客戶產品品質異常分析與制定有效的改善措施 5.具備機構、板金、模具品保經驗尤佳 6.協助新產品導入與認證

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。

群瑞的產品為客製化金屬與塑膠製品，採用多種製程以滿足客戶及產品的需求。 品質工程團隊需嚴謹執行以下工作: 1. 對應國內外客戶，第一時間處理緊急措施。 2. 對應客戶/系統廠進行量產品客訴異常分析與8D報告回覆。 3. 對應供應商分析客訴異常、討論改善對策並進行有效性驗證。 4. 依據客訴對策執行文件修訂或跟催文件變更(如SOP/SIP/QCP/FMEA)。 5. 依據月/季/年之客訴統計分析進行供應商製程稽核與生產驗證。 6. 依據供應商評鑑結果進行定期/不定期之輔導與稽核。 7. 可配合工作需求加班 8. 主管交辦事項。

1. 車用電子零件開發&量產品質管理 2. 供應商品質管理 3. TQM活動推進 4. 成車用品評價

1.負責維護與改善公司內部ISO品質管理體系，確保生產過程與產品符合國際品質標準，並推動內部稽核、改進措施及品質問題的處理。 1依據ISO 9001及相關標準，負責公司品質管理體系的規劃與實施 2主導並協助內部稽核工作，定期檢查品質管理流程的合規性 3協助品質問題的根本原因分析，提出改進方案並跟蹤執行 4配合外部審核，協助準備ISO相關審核資料及報告 5監控並分析品質指標，提出優化建議以提升產品品質及生產效率 6與各部門協調，推動品質改進專案，解決日常生產中的品質問題 7.主管交辦事項

1. New supplier survey and existing supplier audit 2. Support special task related to supplier quality management (ex. onsite supporting and deal with urgent supplier quality issue and yield). 3. For key supplier material quality reviewing and driving improvement a. VLRR/LRR review b. Deal with supplier issue continuous improvement plan. c. SCAR review d. Supplier process audit/review 4. Assigned task supporting (ex. MQC CAMP system maintenance, defective material cost task force, procedure revising.)

1. 新產品NPI階段試產結果的確認及問題改善跟催 2. NPI階段組裝與測試設備的設計與驗證 3. 新產檢驗及測試標準制定 4. 供應商現場稽核 5. 供應商品質管制與評鑒 6. 製程品質稽核與改善效果追蹤 7. 客戶/專案品質管理與改善 8. DOA/RMA的品質改善與追蹤 9. 熟悉TS16949五大工具，SPC/ FMEA/ PPAP/ MSA/ APQP 10. 客訴問題的報告與回復 11. 客戶專案進度掌控/定期與客戶會議

1. 熟悉品保和品管系統規章IATF 16949，規劃與執行品質保証系統。 2. 建立品質發展策略與方案，維持品質系統與執行，進行品質系統稽核。 3. 新產品設計規格測試和檢驗。 4. 供應商的品質管理規範與執行(IQC)。 5. 供應商製程稽核，製程異常之反應、分析、管理和追蹤。 6. 客戶驗貨稽核，成品客訴之反應、分析、管理和追蹤。 7. 產品品質管理及產品檢驗規範訂定(QE)。 8. 執行工作流程，並檢討問題及提出改善方案者。跨部門協調 9. 英文 聽說讀寫良好 10. 有機械工程背景 11. 有工作熱誠, 主動、積極 12. 溝通協調能力佳

主要職責 : 1)管理供應商出貨品質 2)執行供應商品質稽核及輔導改善 3)客戶及製程材料不良分析及後續追蹤改善 4)品質資料統計分析 5)品檢員訓練計劃擬定及實施 6)檢驗儀器設備教育訓練 7)建立材料檢驗品質標準

1. 定期進行品保技術員的教育訓練 2. 各站之異常單處理與彙整、追蹤 3. 供應商品質管理 4. 協助產線與相關製程稽核 5. 協助彙整與稽查相關生產紀錄表單 6. 協助管理品保技術員 7. 配合荷蘭出差(2~3個月) 8. 主管交辦事項

1.供應商APQP審核管理 2.供應商生產品質監控與管理 3.新供應商審核 4.供應商品質問題改善稽核 5.供應商年度稽核 6.供應商變更管理

1. 內部資源協調： 負責整合並協調公司內部各部門（如生產、供應鏈、品質管理等）資源，以確保OEM/ODM客戶的需求得到及時滿足。 參與項目規劃與推進會議，提供專業意見，並確保各項任務按時完成，提升客戶滿意度與信任度。 2. 品質異常處理： 積極協調工廠與研發團隊，針對產品品質異常問題進行深入分析，找出根本原因並制定有效的解決方案。 建立品質追蹤系統，持續監控產品品質，並推動改善措施，確保產品符合公司及客戶的品質標準。 3. 客戶關係管理： 主動接收並處理客戶的反饋與抱怨，確保客戶的需求與期望能夠被重視並迅速回應。 建立與維護良好的客戶關係，定期進行客戶滿意度調查，了解客戶需求變化，並提出改善建議，促進長期合作。 4. 專案管理與報告： 負責專案進度的跟蹤與報告，確保所有相關人員了解專案狀態及未來計劃。 撰寫專案總結報告，分析專案成果與不足之處，為未來專案提供參考。

Responsible for handling customer quality complaints, act as a liaison with other company departments worldwide and interface with OEM factories regarding quality aspects Provide 8D report to Asian customers, evaluate corrective actions for all complaints and assure all of actions are well followed in production process. On specific projects, work closely with PM teams to launch of new products. Such activity would include process check, DFMEA/PFMEA, Q-flow chart check and first-article inspection. Evaluates the supplier processes and process controls to ensure product quality and reliability is compliant. Develops supplier capability with conducting continuous improvement actions. Involved in various audits regarding to connector production process, quality system and plating process. The further tasks will be defined regarding your own skills and team's requests Working location and Business travel: Based in Taoyuan with several business trips in east of China and some in Europe.

※工作海外出差頻度約一年4-8次，主要為中國。偶需出差日本。 ※海外出差單次時間約一週。 ※直屬主管為日籍人士，日常溝通需頻繁使用日文、中文（偶有英文）。 ※薪資依能力、學經歷核定。 工作內容： 1. 委託代工生產方的品質管理相關作業：例行業務包含原材料的進貨品質檢查、製程內檢驗結果確認、生產現場確認（確保按規範執行）。 2.公司產品的品質保證相關作業：出貨檢查結果確認、趨勢管理、庫存品/半成品的品質變動確認、現場/實物調查。 3.客戶應對(與業務單位協調作業)：客戶要求資料的製作（包括品質及環境管理相關內容）、客訴處理（與客戶溝通、不良品現況/實物調查與解析）。 4.執行品質管理系統相關規範。 5.熟悉各類標準規範(IPC、UL、RoHS等)。 6.其餘主管交辦事項。 必要特質： 1.對半導體相關技術及半導體產品需具備一定興趣。 2.在製程或產品發生不良現象時，能夠有耐心地進行原因追查、分析與判斷。

1.Sever production and incoming quality control and review. 2.Cross loop function with team to take over all quality totally improvements. 3.Routine meeting to sync up with all sites for quality improvements. 4.Maintain issues and report for case study and lesson learn improve the quality and workmanship. 5.Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements. 6. OEM models first build production follow up and issues tracking. 7.Establish and implement quality standards, optimize procedure, and update documents. 8.Nonconformance analysis and implementing corrective actions to prevent recurrence. 9.Sync up with production issue follow up and lesson learn with team.

1. 擔任品牌窗口，能以英文與客戶協調溝通專案推動； 2. 推行並落實品管制度與規劃品質系統相關之教育訓練； 3. 持續優化品質管理機制，全面提升產品品質與可信賴度； 4. 統籌品質異常處理分析、客訴退貨調查與相關改善； 5. 承接品牌 KPI 指標，完成各項專案稽核並達到年度成績。

1.外包廠導入前稽核與資格評估 2.品質標準與製程條件確認 3.品質教育訓練 4.生產當下品質監控 5.品質異常處理與回報制度 6.定期稽核與績效回饋 7.適時安排出差/長期駐廠