QA - Engineer (Product)

【在醫療器材產業中，品質絕對是擺在第一位！】
我們是以「專案」進行分工，你將在這個專案中成為QA的代表，因此會了解整個產品的製造流程！

【Main Responsibilities】
‧ Lead / participate in project related quality activities (e.g. design control, change control, product release) and provide quality consultation to the team.
‧ Demonstrate customer focus, cross-functional cooperation skills, and sound quality judgement.
‧ Complete the evaluation and detailed investigation on the observed nonconformities during manufacturing process.
‧ Present accumulated quality data to customers and management.
‧ Identify trends of quality data with the usage of statistics and quality improvement tools to prevent quality issues.
‧ Ability to effectively communicate and interact with foreign customer, team members, and various technical disciplines.
‧ Support external quality inspections and execute internal and supplier audits.
‧ Complete assigned tasks on time with minimal supervision (self-motivated).
‧ 領導/參與與專案相關的品質活動，並向團隊提供品質建議。
‧ 必須展現以客戶為導向的態度，跨部門合作技巧以及良好的品質判斷能力。
‧ 在製造過程中對觀察到的不符合項目進行評估和詳細調查。
‧ 向客戶和管理層呈現累積的品質數據。
‧ 利用統計和品質改進工具識別品質數據的趨勢，以預防品質問題再犯。
‧ 能有效地與外國客戶（歐美及日韓地區居多）、團隊成員和各種技術專業互動和溝通。
‧ 支援外部品質檢查並執行內部和供應商審核。
‧ 能在時間內主動積極的完成被分配的任務

【Required Skills & Qualifications】
‧ Programming or system development experience required; QA system experience is a plus (e.g., URS owner, QA app development, or IT liaison for QMS).
‧ BS degree above or equivalent technical work experience.
‧ Clear / logical thinking with strong organization and communication skills
‧ Proficient problem solving skills.
‧ Working knowledge of Microsoft Office.
‧ Experience in the medical device industry is preferred.
‧ Knowledge of regulatory compliance: GMP (good manufacturing practice), QSR (quality system regulations), and ISO 13485 is preferred.
‧ CQT (certified quality technician), CQE (certified quality engineer) is a plus.
‧ Six sigma green belt or black belt is a plus.
‧ 需具備程式或系統開發經驗；具QA系統經驗尤佳，如URS負責人、QA系統開發或QMS之IT窗口
‧ 工程學士學位以上或品質/製成相關工作經驗。
‧ 具有清晰/邏輯思維和良好的組織和溝通能力。
‧ 熟練的解決問題能力。
‧ 熟悉Microsoft Office軟體。
‧ 具有醫療器械行業經驗者優先考慮。
‧ 熟悉法規合規要求：GMP、QSR、和ISO 13485者優先考慮。
‧ 持有CQT（認證品質技術員）、CQE（認證品質工程師）證書者優先加分。
‧ 擁有六標準差綠帶或黑帶證書者優先加分。