QA - Audit Engineer
Taoyuan, Taiwan
SHL (Scandinavian Health Ltd) is currently the world's largest privately-owned designer, developer and manufacturer of advanced drug delivery systems. The organization was established in 1989 by Swedish entrepreneurs Roger Samuelsson and Martin Jelf with the goal of combining world-class manufacturing in Asia with the strengths of Western Management practices. SHL manufactures devices including pen injectors, auto injectors and inhaler systems. We also manufacture a range of other products including pressure mattress systems, patient lifting slings, medical soft goods, beds, neurosurgical devices, catheters and industrial equipment.
瑞健集團(SHL)成立於1989年,目標以西方管理模式在亞洲打造具有國際水準的生產中心。如今,在全球製藥及生物科技領域,SHL已成為藥物輸送系統的OEM/ODM領導製造商,如自動安全注射器。除此之外,SHL還擴展許多產品線,像是軟性結構類醫療產品、醫療氣墊床、醫療床、腦神經手術器具、工業 設備和醫療用吊昇設備等,目標市場為北美、歐洲及亞洲。
【Job Overview】
To support risk-based approach audit events including audit preparation, audit awareness training and verify effectiveness of CAPA process. 協助進行風險導向的稽核活動,包括工作準備、稽核認知培訓,還有確認 CAPA 流程的有效性
【Responsibilities】
- Responsible for audit preparation, coordinating and organizing internal/external audits
- Assist in development of audit plan, audit schedules, audit report and follow-up audit findings till closure
- Support the site corrective and preventive actions process
- Collect & analyses data analysis for internal/external audit performance
- Training employees on GxP and quality standards and procedure to ensure audit readiness
- Maintaining documentations and procedures within the QMS
- Keep abreast of industry standards and regulations
- Carry out other duties as assigned by the supervisor or management.
- 負責稽核準備及協調組織內部/外部稽核工作。
- 協助制定稽核計劃、安排稽核進度、撰寫稽核報告,並跟進稽核發現直至結案。
- 支援現場的矯正和預防措施流程。
- 蒐集並分析內部/外部稽核績效的數據。
- 培訓員工關於GxP及品質標準和程序,以確保隨時具備稽核準備。
- 維護品質管理系統(QMS)中的文件和程序。
- 緊跟行業標準及法規的最新動態。
- 執行主管分配的其他任務
【Qualification】
- Bachelor’s Degree in Engineering, manufacturing ,technical discipline, other related science is required.
- Minimum 3 years’ experience in Quality Assurance related function, Medical Device, Bio-Pharmaceutical or other regulated industry.
- Familiar with 21 CFR 820, ISO13485, cGMP is preferred.
- Trained internal auditor in ISO 13485 / ISO 9001 or equivalent will be an added advantage.
- Experience in managing external quality audit will be an added advantage.
- Knowledge of Quality Tools, auditing technique, problem solving skills is preferred.
- Able to work well in a cross functional team and manage your own job load independently.
- Well-versed in English and Chinese, read, written and communicate.
- Attention to details, keen interest in compliance and continual improvement matters.
- 需具備工程、製造、技術相關領域或其他理科相關學士學位 。
- 至少3年品質保證相關經驗,醫療器材、生物製藥或其他受管制產業尤佳。
- 熟悉21 CFR 820、ISO13485、cGMP者優先。
- 具ISO 13485 / ISO 9001或同等內部稽核訓練者尤佳。
- 有管理外部品質稽核經驗者尤佳。
- 熟悉品質工具、稽核技巧及具備問題解決能力者優先。
- 能夠在跨部門團隊中協作良好,並能獨立管理自己的工作量。
- 中英文讀寫溝通能力佳。
- 細心,對法規遵循與持續改進有濃厚興趣。