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職位描述
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職位類別: 品質工程師
Job summary: Responsible on designing and developing protocols to be fulfilled so that the products under manufactured meet policies, procedures, regulatory requirements. Sr. Validation Engineer Implements policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements of company, industry, countries’ legislation manufacturing standards. Responsibilities: 1. Validation Evaluation for new or modified process/equipment system/facility a) Process characterization study; b) Identify key process variables that would affect product quality c) Identify equipment critical part/feature that would affect process parameter and product quality d) Hazard Analysis/risk assessment and other process study e) Develop VMP for whole processes of production by product with necessary justifications based on above assessment/study 2. Design and develop validation protocol a) Design validation study features, such as sampling, testing, or analytical methodologies. b) Direct validation activities, such as protocol creation or testing. c) Prepare validation protocols for new or modified manufacturing processes, systems, or equipment for medical, electronics, or other types of production. d) Study product characteristics or customer requirements to determine validation objectives and standards. 3. Conduct validation or qualification tests based on internal protocols and/or external standards. a) Assist in training operators or other staff on validation protocols. b) Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems. c) Coordinate the implementation or scheduling of validation testing with affected departments and personnel. d) Identify deviations from established product or process standards and provide recommendations for resolving deviations. e) Manage deviations and changes in order to guarantee that these are well documented and corrective actions are taken and followed-up upon. f) Draw samples of raw materials, or intermediate and finished products for validation testing. g) Conduct audits of validation or performance qualification processes to ensure compliance with internal or regulatory requirements. h) Procure or devise automated validation test stations or other test fixtures and equipment. i) Align facility validation strategies and policies with actual outcomes 4. Continuous competence development in Validation and maintenance of validation documentation and database a) Communicate with regulatory agencies regarding compliance documentation or validation results. b) Participate in internal or external training programs to maintain knowledge of validation principles, industry trends, or technologies. c) Prepare, maintain, or review validation and compliance documentation. d) Create, populate, or maintain databases for tracking validation activities, test results, or validated systems. 5. Deal with other assignments assigned by superior. Qualification: 1. Bachelor or above, major in electronics, electromechanical or equivalent. 2. Above 6 years relative work experience, QA experience is a plus. 3. Good command of reading & written English. 4. proactive, responsible, independent.查看更多
- 年齡要求: 不限
- 語言要求: 英語

郭先生
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公司介紹
公司簡介 30多年來,Quasar 始終精耕細作,致力于為客戶提供全面的全承包解決方案,從最初過程設計到大批量生產,為客戶提供一系列不同的制造能力、專業支持以及項目優化服務。這種綜合性工藝過程開發方法,是客戶實現高品質的保證,同時還能節約成本。Quasar擁有全部國際相關證書,包括 ISO 13485:2016、cGMP 認證等,并嚴格遵守 IP 防護標準的規定。 Quasar的業務遍布全球,總部設在新加坡和香港,工程辦公室設在以色列,在中國有三個制造工廠(分別位于深圳和東莞),在泰國有一個新建的制造工廠,在美國有一個業務發展部門。Quasar 擁有超過3000名員工,是微創醫療器械制造行業的市場領導者。我們的客戶包括強生公司、美敦力以及雅培等大型跨國企業。查看更多
工商信息
- 公司名稱: 秋時電子科技(東莞)有限公司
- 公司狀態: 存續
- 行業: 批發業
- 公司類型: 有限責任公司(臺港澳法人獨資)
- 地址: 東莞松山湖高新技術產業開發區臺灣高科技園桃園路1號莞臺生物技術合作育成中心8號樓
- 企業規模: 小于50人
- 法人代表: 阿耀·阿米泰
- 注冊資本: 200萬美元
- 注冊時間: 2017年03月02日
- 注冊號: 441900400225064
- 統一社會信用代碼: 91441900MA4W8XLG1J
- 組織機構代碼: MA4W8XLG1
- 登記機關: 東莞市工商行政管理局
- 注冊地址: 東莞松山湖高新技術產業開發區臺灣高科技園桃園路1號莞臺生物技術合作育成中心8號樓
- 營業期限: 2017-03-02至2047-03-02
- 核準日期: 2017年06月23日
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經營范圍:
生產、設計、研發、技術咨詢、批發:電子產品、電機設備、光學設備、計量檢驗設備及零配件、精密儀器設備及其零配件、塑料和橡膠制品及其附件;貨物及技術進出口。(以上項目不涉及外商投資準入特別管理措施)。(依法須經批準的項目,經相關部門批準后方可開展經營活動)〓
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工作地址
廣東省東莞市東坑鎮興業路2號機器人產業園5棟
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