欧美在线视频,乱熟女高潮一区二区在线 ,女厕精品toilet,免费看成人啪啪

更新于 12月28日

Sr. Validation Engineer 高級驗證工程師

1.2-1.8萬·13薪
  • 東莞
  • 5-10年
  • 本科
  • 全職
  • 招1人

職位描述

醫(yī)療器械體系ISO3485英語熟練醫(yī)療設(shè)備/器械
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.

工作地點

東莞QUASAR秋時興業(yè)路2號機(jī)器人產(chǎn)業(yè)園5棟

職位發(fā)布者

李輝/人事經(jīng)理

立即溝通
公司Logo秋時電子科技(東莞)有限公司
公司主頁
主站蜘蛛池模板: 枣庄市| 汝城县| 建瓯市| 涡阳县| 综艺| 三明市| 金川县| 斗六市| 蕲春县| 炉霍县| 衡阳市| 宣汉县| 大理市| 科技| 乌兰浩特市| 永德县| 东乡| 定襄县| 河曲县| 临城县| 喀喇| 丰宁| 德令哈市| 轮台县| 都兰县| 布尔津县| 澄迈县| 汝城县| 辽阳县| 河北省| 丹凤县| 渝中区| 紫金县| 阳新县| 梨树县| 正定县| 利川市| 徐汇区| 太康县| 武川县| 个旧市|