品管/品保主管的職務定義 Show
掌管公司內部品質管制業務之規劃、協調、指導及考核等活動之管理者 品管/品保主管的工作內容
品管/品保主管的最新推薦工作
品管/品保主管的Holland職業類型品管/品保主管的職涯發展品管/品保主管的面試經驗暨工作甘苦談品管/品保主管的相關職能
品管/品保主管的下一份工作※ Job Purpose: Conduct onsite Social Accountability audit, Security Audit, and Factory Evaluation FE (or Factory Assessment FA) as assigned by the coordinators, and complete the audit reports. ※ Principal Accountabilities: 1. Perform audit job according to company’s schedule, and complete audit report base on the actual findings. 2. Good communication with office staff, colleague, and factory representative. 3. Able to perform all kinds of audit service type individually. 4.
Return the audit handling kit, retained photographs, and any related materials and documents and records to the operating office, and complete final typed report based on actual finding and company/client’s requirement within the deadline required by BV. 5. Responsible to reply report reviewing team on timely basis without any delay. 1.機台檢核、備品裝箱、清潔出貨 2.成品及半成品進料檢驗及資料登載 3.持續性的分析、改善及追蹤原物料不良品 4.開發與改善產品品質的管理流程 5.客訴問題處理、分析與改善追蹤 6.ISO 9001品質系統文件之建立與維護 7.主管交辦事項 1. 原、物料、成品、研發新品的品質判定。 2. 協助品管相關制度維護,現場製程管制。 3. 現場人員品質教育訓練計劃執行 4.其他部門業務相關交辦事項 1. 執行線上品管作業,隨時巡檢、抽檢 2. 執行原物料進貨驗收 3. GHP文件維護與執行(ISO & HACCP),食品業者登入平台維護更新(非登不可、非追不可) 4. 食品衛生檢查(人員服裝儀容、機具設備清潔、冷藏冷凍倉儲原物料定位、效期檢視) 5. 督導稽核廠區清潔工作 6. 執行衛生教育訓練 7.
須具備食品相關產業品保經驗二年以上。 負責工作管理 SQE/PQE/CQE 工程師,應對國內外客戶需求 1.SQE工程師管理 : 供應商管理,依照公司管理規範進行供應商核可,稽核,來料進行異常確認及處理,改善依照客戶需求進行供應商GR&R,新材料圖面確認檢驗項目,限樣確認收集給IQC。 2.PQE管理 : 生產 Cpk 管控,生產異常PPAR
開單,利用系統管理及記錄,與生產單位討論改善措施檢視新產品工程單位量測方法是否符合客戶規範,產品量測GR&R,MSA,Cpk管理建立自動化監控報表。 3.CQE工程師管理 : FATP 後段資訊統整及回饋,異常處理及判斷,配合客戶需求。 1. 熟稔食品法規,負責品保業務及專案改善項目 2.
食品安全管理系統維護及受稽負責 3. 客訴案件調查及改善預防 4. 供應商稽核與管理 5. 檢驗實驗室之監督管理 6. 品管業務之跟催與掌控 7. 主管交辦事項 待遇面議 1.製程品質管理、物品、設備存貨地點環境分析,依物品或設備特性找尋合是儲藏地點,排除儲存過程中可能帶來危害品質之物品
2.物品、設備、供應商、客戶服務等品質管理制度建立使物品、器材等品質符合標準 3.所需表單資料規劃,如: 品質檢驗表、檢測數據記錄表等 4.品保人員工作職掌分配、品保系統作業標準化,持續改善品質管理流程 Responsibilities & Authorities: 1. Responsible for quality oversight and execution for medical devices during the product lifecycle and the associated Quality System. 2. Work on assigned projects as the QA representative to support the business to ensure the design
control process, relevant activities, and design history files (DHF) are in co Establishes and maintains the QMS, ensuring it is capable of consistently meeting US FDA, EU MDR/IVDR, ISO 13485, TW QMS, other applicable regulations and other customer requirements. 3. Serves as the Quality Management Representative for Local site for 3rd party and regulatory audits and oversees and excutes quality management review and quality audit processes and reports to Director of Division. 4. Develops and
deploys the quality plan ensuring alignment with QMS, regulatory and customers' requirements. 5. Direct and manage Quality Team for quality oversight or execution of the quality assurance assurance in different sites and quality control activities in local site for all projdcts during the product lifecycle and the associated Quality System. 6. Develops, implements, and manages processes to ensure that products meet required specifications for quality, function, and reliability prior to delivery.
7. Manages the CAPA process and review board for ensuring all employees associated with CAPA action items have the capabilities and resources to complete their assignments. 8. Direct team member and manage processes for deviations, risk assessments and nonconforming material reports. 9. Handle and manage product RMA, complaint process, inquiry requests or investigations in accordance to client or regulator’s requirements. 10. Oversees and supervises the change control process and approval. 11.
Responsible for the assigned projects as the QA representative to support the business to ensure the design control process, relevant activities, and design history files (DHF) are in compliance with internal QMS and regulatory requirements. 12. Engages with and influences the management team and other stakeholders such as product development, logistics and suppliers to maintain a focused quality culture within the facility. 13. Ensures the facility process validation system is executed
appropriately and maintains compliance to medical device expectations and master validation plans. 14. For the assigned manufacturing sites, ensures finished product shipped from the facility conforms to the Finished Product Specification and Compliance of Certificate (CoC) for product release and is documented in a device history record. Has authority to hold non-conforming or potentially non-conforming product. 15. Ensures incoming materials meet raw material specifications with the authority
to reject nonconforming raw materials. Communicates material issues and partners with suppliers to improve performance through the SCAR (Supplier Corrective Action Request) process as appropriate. 16. Ensures that processes are delivering on their intended outputs by selection and review of critical quality KPIs and run to target methodologies. 11/23 品保工程師
1.品質系統維護 2.客訴分析對應 3.量規儀器校正與管理 4.可靠度測試與管理 5.有害物質風險管理 6.供應商評估與輔導. 7.需支援產線加班、無管理責任 11/23 品管儲備幹部
1. 熟悉ISO相關法規作業。 2. 熟悉衛福部相關法規作業。 3. 熟悉ERP文書作業。 4. 熟悉品管相關知識。 5. 日常品管作業(抽驗/品管問題分析)。 6. 品質教育訓練擬定與執行。 7. 統計分析資料與產品規格擬定。 8. 其他主管交辦其他事項。 11/23 品保儲備幹部
1.負責公司品管體系建立。 2.對各種品質問題進行分析及矯正預防措施。 3.改善品質信賴度、可靠性、全面提升產品品質。 4.負責ISO/GMP體系之推行、供應商管理。 5.推行並落實QA管理制度。 6.規劃品質系統相關教育訓練。 7.協助內部稽核活動及外部認證. 8.主管交辦事務. 11/23 非破壞檢測人員
一、協助執行NDT非破壞檢測 ,本公司無從事輻射檢測的項目。 二、公司會輔助考取NDT相關證照,考取後每月增加證照加給。 三、加班、特休、均依照勞基法相關規定執行。 四、有勞健保及意外傷害險。 五、中餐由公司提供。 六、工作地點:麥寮六輕。 七、工作有時候必須要爬高。 八、有三節獎金、年終獎金、公司旅遊、聚餐(疫情期間暫停舉辦) 九、明年元旦會再調薪 11/23 品工主管
1.產品估價及成本製作 2.品工課事務 3.產品料表(BOM)結構與製程規劃 4.廠內外產線異常狀況排除 5.修包成本及修包結構建置 6.新產品資訊 7.改善生產製程工序 8.新品開發事項 11/23 品保人員
1.三次元(CMM)量測儀器操作…等。 2.產品品質檢驗及相關檢驗數據記錄及彙整。 3.不良品處理及溝通。 4.主管交辦事宜。 11/23 品質管理專員
1.熟知量產品質要求與現場管理手法 2.品質系統建置及管理 3.負責製程品質檢驗工作 4.具品質管理的各項事務 5.熟悉鈑金、焊接、印刷、陽極、ISO規範等事務 6.客訴處理及主管交辦事項 11/23 (台中)QC小分子組(副)組長
1. 組內所屬人員之工作安排(原物料/中間體/安定性)、領導管理 2. 實驗室異常事件調查 3. 藥典更新方法導入 4. 確保cGMP相關程序執行,符合法規要求 5. 設備維護及校驗執行 6. 分析方法SOP/確效計劃書制定 7. 其他主管交辦事項 11/23 QE工程師
1. 客返品測試與解析。 2.試作品測試與解析。 3. 8D報告彙整與作成。 4. 改善對策水平展開。 |