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.
