香港商陽碩利華有限公司台灣分公司
ISO/QMS/文管中心管理師
10/7 更新
Array
全職
中高級
英文 條件要求
11 ~ 30 應徵者

職務概況

待遇面議
(經常性薪資達 4 萬元或以上)
台中市西屯區

條件要求

語文條件
英文
聽/中等、說/中等、讀/中等、寫/中等
工作經歷
2年以上

職務描述

香港商陽碩利華公司台灣分公司主要為專業設計、研發及生產輔助性醫療器材設備,如磨指甲機、牙醫床設備, 皮膚照護及外科手術儀器等等。 歡迎優秀年輕朋友們,對電子產品開發設計製造和品質管理有興趣者,加入我們的行列。
本公司文管中心管理師/ISO/QMS品質系統維護職務內容說明如下:
文管中心的管理與維護:
1. 品質管理系統文件建立、管理、發行、回收 與文件管制相關作業
2. 發行文件及檔案(包括文件、圖面、記錄、驗證報告) 的記錄、分類、整理、歸檔及保管
.文件編碼/搜集/審查/分類/整理/維護
.文件列印/管制章/歸檔(紙本)/目錄及索引建置/維護
.文件跟催/發行/回收/調閱/借出/歸還管理
3. 負責外部客戶文件更新、發行、審核與跟催等作業
4. ERP建立產品料號和維護(包括產品規格, 圖檔, BOM 版次)的更新和控管
ISO 13485品質系統的建立與維護:
1. 負責ISO 13485、QMS相關品質文件管理與系統維護, 包含流程及需求表單建立
2. 品質管理系統文件編寫, 確保品質系統之符合性運作相關作業
3. 協助品質系統推行,並進行系統的稽核,以確保品質系統實施的有效性
4. 負責國內外醫療器材法規認證事務及相關法規、標準之收集與更新
5. 協助內部稽核活動及外部稽核認證
7. 其他主管交辦事項或專案執行
QA職責:
1. 協助品質系統推行,並進行現場的稽核及確保品質作業一致性
2. 品保資料處理與分析, 整合品質月報/季報/年報
3. 監督和改善各項品質活動, 督導內部依QMS規範執行
Management and maintenance of the document center (DOCC):
1. Quality management system document establishment, management, issuance,
recycling and document control related operations
2. Recording, classifying, sorting, filing and keeping of issued documents and
archives (including documents, drawings, records, verification reports)
.File coding/collection/review/classification/organization/maintenance
.Document printing/control seal/filing (paper)/directory and index
creation/maintenance
.Document tracking/issuing/recycling/requesting/lending/returning management
3. Responsible for the update, release, review and follow-up of external customer
documents
4. ERP establishes product article numbers and maintains (including product
specifications, drawings, BOM version) update and control
Establishment and maintenance of ISO 13485 quality system:
1. Responsible for ISO 13485, QMS related quality document management and
system maintenance, including process and requirement form establishment
2. Compilation of quality management system documents to ensure the compliance
operation of the quality system
3. Assist in the implementation of the quality system and conduct systematic audits
to ensure the effectiveness of the implementation of the quality system
4. Responsible for the collection and update of domestic and foreign medical
equipment regulatory certification affairs and related regulations and standards
5. Assist in internal audit activities and external audit certification
QA Responsibilities:
1. Assist in the implementation of the quality system, conduct on-site audits and ensure the consistency of quality operations.
2. Quality assurance data processing and analysis, integrating monthly/quarterly/annual quality reports.
3. Supervise and improve various quality activities, and supervise internal implementation in accordance with QMS specifications.
需求人數
1~1人
學歷要求
專科以上
科系要求
商業及管理學科類、醫藥衛生學科類、工程學科類
上班時段
日班
休假制度
週休二日

工作技能

Document Processing/Typing Skills
Document
ISO document release management
Handling document updates
Familiar with document control procedures (DCC)
Computerized file management strategy
Establishment and maintenance of a document management center
Product Verification Operations
Planning and Implementation of Quality Management System
Standard Operating Procedure Planning
文書處理╱排版能力 文件檔案資料處理、轉換及整合工作 ISO文件發行管理 負責文件更新、發行、審核與跟催作業 熟悉文件管制作業程序(DCC) 檔案管理之電腦化策略 文件管理中心之建立與維護 標準作業流程規劃 產品驗證作業 規劃並執行品質管理系統
職務類別
Document Controller
Operations Manager/System Integration/ERP Specialist
ISO / Quality Assurance Staff
台中市西屯區
醫療器材製造業
香港商陽碩利華有限公司台灣分公司創立於民國88年,致力於醫療器材設備及其它工業和消費性電子產品的研發設計和製造生產;主要以OEM/ODM專案為主, 透過研發和製造優良品質產品外銷世界各地並嘉惠客戶和終端使用者。 本公司擁有優秀的經營團隊,秉持著『Innovative Quality Solutions 創新品質解決方案』的經營理念,追求企業永續經營及成長;除整體營運穩定外,獲利狀況逐年提昇,是國內績優廠商之一 。為求更具競爭力, 公司並於民國109年取得 ISO 13485:2016 和 ISO 9001:2015品質管理系統認證, 繼續努力研發和製造優良醫療儀器和產品以幫助更多人的健康管理和照護! 我們重視每一位員工,除了有良好工作環境和福利制度、也提供學習及成長的空間,歡迎優秀的朋友和夥伴們一起加入香港商陽碩利華有限公司台灣分公司的工作行列。 COMPANY INTRODUCTION WHAT WE DO We are pleased to introduce ourselves, Yellowstone Technology, a company with European roots located in Taichung city (Xitun Dist.), Taiwan, as an eminent name in the field of Medical Healthcare product design, development and manufacturing. WHO WE ARE LOOKING FOR Thanks to the increasing rate of new product development enquiries, and our desire to develop a larger and stronger creative development team, our company is on the lookout for new members to join our dynamic, professional aiming team. Yellowstone is an exciting place to work with challenging and a diverse projects portfolio for which we are currently offering some exceptional job opportunities. The successful candidate will apply extensive technical expertise to develop new and improve existing product designs, including development, analysis, prototyping, and testing. We are committed to excellence in our people, products, performance, and profits. We value our employees and their contributions to our success; product innovation and product quality; continuous improvement through total quality management; environmentally sound and responsible business practices; honesty, integrity, and social responsibility in our business; and customer service. We believe our employees are the foundation of our Company’s success, and we are committed to continuous learning and quality, focusing on the customer, respect and accountability, flexibility, and good relationships with others. We are always interested in hearing from candidates who believe their talents and passion can make a difference. If you are a fast learner with a solution-oriented attitude and excellent problem solving skills, do not hesitate to contact us even if your qualification does not tick every box. We offer a full-time position in a nice and well organized working environment. We aim to help you develop your career, in terms of technical skills as well as business and customer experience. Join our company, where you will have the opportunity to familiarize with cutting edge technologies and tools, and have true responsibilities that allow you to make a real impact. Applicants should have exceptional motivation, independent working ability, be a self learner eager to acquire new skills or technologies and apply those in your future work. Fluency in English and Mandarin both spoken and written is a must.
11 ~ 30 應徵者