職位描述
職位職責 (簡要說明)
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? Responsible for new product quality plan and make sure compliance of medical device regulation and quality system
? Responsible for legacy product maintenance and continuous improvement.
? Responsible for customer complain investigation, risk analysis, corrective and preventive action, effectiveness, handle customer complaint in time, continuous improve the customer satisfactions,
? Responsible for organize related department on non-conforming product review and disposition.
? Drive and implement process improvements to achieve First Time Quality (e.g. Error proofing, Measuring Automation activities, Yield improvements)
? 負責新產品質量管理策劃, 確保其醫療器械法規和體系的符合性;
? 負責老產品的維護和持續改進；
? 負責客訴的調查、風險分析、糾正和預防措施及其有效性, 及時處理客訴，持續提升客戶滿意度；
? 負責組織相關部門對不合格品評審和處置。
? 驅動和實施過程改進，達成FTQ（First Time Quality）（如防錯、自動測量、提高產量）。
主要工作內容/職責（列舉清單）
Responsibility （List）
? Responsible for new product quality planning, ensure compliance with medical regulation and system requirement.
? Responsible for legacy product maintenance and continuous improvement.
? Responsible for customer compliant investigation, risk analysis, corrective and preventive action and effectiveness, deal with customer complaint in time, continuous improve customer satisfactions.
? Lead Material Review Board (MRB) to dispose nonconforming material, identify the root cause and initiate corrective/preventive actions to eliminate defects. (e.g. Flow chart, 5 Why, Fish bone)
? Responsible of effective implementation of corrective and preventive action, advisory notice and adverse event report and continuous improvement.
? Accomplish responsible work per priority in a high quality and high efficiency manner, even under multi-task pre-condition.
? Continuous improve product quality and process.
? Designs and/or implements methods and procedures for inspecting, testing, and evaluating the precision and reliability of products and/or production and/or test equipment. (e.g. Gage design, GR&R )
? Responsible for inspection method training, and standardize inspection method, come out with work instruction.
? Ensure all process variables and their interactions are adequately defined. Ensure all failure modes in process have been identified and addressed. (e.g. Use of DOE studies, FMEA’s, Risk Reduction)
? Define process, product and test method validation requirements, preparation and approval of validation protocols and reports. (e.g. EIQ/EOQ/POQ/PPQ)
? Prepare weekly report\monthly report from raw material to finished goods full process quality per company and department target and come out with corrective preventive action, in order to meet target.
? Attend to maintain and monitor quality system running and organization, internal quality audit.
? Accomplish task assigned by leader.
? 負責新產品質量管理策劃, 確保其醫療器械法規和體系的符合性;
? 負責老產品的維護和持續改進；
? 負責客訴的調查、風險分析、糾正和預防措施及其有效性, 及時處理客訴，持續提升客戶滿意度；
? 負責主導MRB物料評審委員會對不合格品評審和處置，識別根本原因，啟動糾正/預防措施消除缺陷，如：流程圖、5-為什么、魚骨圖。
? 負責糾正預防措施有效實施、忠告性通知和不良事件報告及持續改進工作；
? 負責在多任務的前提下，按照優先級，高質量和高效率地完成本職工作；
? 持續改善產品質量和流程；
? 負責滿足程序的檢驗、試驗方法的設計和開發，評估檢驗、試驗方法或產品/過程/測試設備的精度要求、可靠性，如：檢具設計、MSA)；
? 負責培訓檢驗員檢驗方法，并標準化檢驗方法，形成作業指導書。
? 確保過程所有變量和影響因素被充分定義，確保所有的過程失效模式被充分識別和解決，如：使用DOE研究，FMEA，降低風險：
? 確定過程、產品和試驗方法驗證要求，準備和批準驗證方案和報告(e.g. EIQ/EOQ/POQ/PPQ)。
? 根據公司整體質量目標和部門目標，針對原材料至最終產品全過程質量的分析周報、月報，并形成必要的糾正預防措施，達成目標；
? 參與維護、監督質量體系的運行、組織和內部質量審核工作；
? 完成上級委派的其它任務。
任職資格 Qualification
知識/教育程度 Knowledge / Education level
? Bachelor Degree，major in mechanical or engineering
? College degree, if with equivalent experience
? 本科學歷，機械、工程專業，
? 大專學歷，若有相當資深的工作經驗也可
經驗/能力要求 Experience/Ability Requirement
? More than 2-3 years working experience in this position, working experience in medical device industry is preferred.
? Proficiency in AutoCAD, MS-office, statistical software, Minitab;
? Familiar with APQP, PPAP, MSA, quality control methods, statistical process control, 6-, Sigma
? ISO9001:2000, TS16949 internal auditor experience, ISO13485 internal auditor experience is preferred;
? With the quality system and CAPA system working experience.
? With ability to work independently and capable of working with a cross functional team.
? With multi-task experience
? With good skill of listen, written and oral English;
? 2-3 年以上本崗位工作經驗，有醫療器械行業工作經驗為佳；
? 熟練使用AutoCAD，MS-office，統計軟件Minitab；
? 熟悉APQP, PPAP, MSA, 質量控制方法, 統計過程控制，6- Sigma,
? ISO9001：2000，TS16949 內審員經驗，有ISO13485內審員經驗優先；
? 具備系統的質量體系和CAPA的工作經驗
? 具備獨立工作能力并有和跨功能團隊工作的能力
? 具備多任務的工作經驗
? 良好的英語聽說讀寫能力;
