东莞招聘

职位描述：
Quality Engineer

Key Accountabilities:
* Responsible to assure that manufacturing processes comply with the product specification and regulatory government agencies requirements. Provide mechanisms for controlling the total quality and establish ways of evaluating the quality of our products.
* Responsible to develop, modify, apply, and maintain standards for quality operating methods, processes, systems and procedures related to software applications and ensure compliances to corporate and regulatory level. Responsible to develop overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements and objectives.
* Assure that processes comply with specifications, Quality Systems Regulations and ISO standards. * Document that processes complies, with a high confidence level, the tolerances stated on the product specification and drawings.
* Establish mechanism to evaluate, measure, monitor and/or quality in our products.
* Evaluate product/material discrepancies. (PRB/MRB) on time, and implement corrective actions accordant.
* Participate in the qualifications and validations of product/equipment and processes.
* Provide check and balance to manufacturing/system changes submitted by manufacturing Engineers.
* Work on special projects assigned by Supervisor/Manager.
* Support manufacturing activities by also participating on production meetings.
* Update manufacturing processes in order to reflect quality concepts and specification requirements.
* Apply statistical tools in order to assure that processes comply with the specifications.
* Ensure compliance to audit findings in a timely manner.
* Conduct failure investigations in order to initiate, stimulate, and assign corrective action. Issue written reports and update, accordingly.
* Develops, modifies, applies, and maintains standards for quality operating methods, processes, systems and procedures related to software applications and ensure compliances to corporate and regulatory level.
* Develops overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements and objectives.
* Reviews and approve software design, change specifications, and plans against contractual and/or process requirements.
* Performs or directs verification of software requirement allocations, traceability, and testability.
* Review and approve software test plans and procedures and oversees all applicable compliance related to manufacturing software.
 
Experience and Knowledge:
* Minimum 3 years’ experience in Engineering related to manufacturing environment. Preferably in a quality assurance functions.
* Must have an aggressive practical personality capable of recognizing problems, causes, and solutions.
* Experience in the medtech / pharma industry will be added advantage.
* Experience in software validation, UAT and documentation of test cases will be added advantage. * Familiar with FDA 21 CFR Part 11 will be advantageous.
 
Qualifications:
* Bachelor Degree in Engineering, Information Management, Computer Sciences or relevant experience.

质量工程师

主要职责：
* 负责确保制造过程符合产品规范和管理政府机构的要求。提供控制总质量的机制，并建立评价我们产品质量的方法。
* 负责制定，修改，使用，和维护质量的操作方法，标准，流程，系统和应用软件的相关程序，确保遵守公司和监管水平。负责制定整体的操作标准，以确保软件质量计划的实施，根据项目，过程和合同的要求和目标。
* 确保过程符合规范，质量体系法规和国际标准体系标准。
* 文件，处理符合，具有高置信水平，在产品规格和图纸上注明的公差。
* 建立机制，以评估，测量，监测和/或质量在我们的产品。
* 评估产品/材料差异。（PRB / MRB）的时间，和实施的纠正行动一致。
* 参加资格和产品/设备和工艺验证。
* 为制造工程师提交的制造/系统变更提供检查和平衡。
* 在主管/经理分配的特殊项目上工作。
* 通过参与生产会议，支持生产活动。
* 更新制造工艺以反映质量概念和规格要求。
* 应用统计工具，以确保过程符合规格。
* 确保符合审计结果的及时。
* 进行故障调查，以启动、刺激和分配纠正措施。发出书面报告和更新，因此。
* 开发、修改、应用、维护质量的操作方法，标准，流程，系统和应用软件的相关程序，确保遵守公司和监管水平。
* 开发整体的操作标准，以确保软件质量计划的实施，根据项目，过程和合同的要求和目标。
* 审查和批准软件设计，变更规范，并对合同和/或工艺要求的计划。
* 执行或指导软件需求分配、可追溯性和可测试性的验证。
* 审查和批准软件测试计划和程序，并监督与制造软件相关的所有适用的合规性。

经验与知识：
* 至少3年以上制造业相关的工程经验。优选在质量保证功能。
* 必须有一个积极的实践能力，能够识别问题，原因和解决方案。
* 在医疗/制药行业经验优先。
* 软件测试经验，测试以及测试案例文档优先。
* 熟悉FDA 21 CFR Part 11者优先。

学历：
本科以上学历，工程、信息管理、计算机科学或相关工作经验。

待遇：
4000~6000新元/月, 视经验而定 举报 分享

江苏亿涛对外经济合作有限公司，是从事对外经济合作的专业公司。立足于中国国内的广大市场，开发中国的各类人力资源优势，不断提高公司的服务水准，努力建立国际性的服务品牌，竭诚向国内外客户提供最优质的服务。 ？？2006年，中国劳动部批准为合格的境外就业中介机构。劳社境外就准字[2006]年452号。 ？？2009年，中国商务部批准为对外劳务合作经营资格企业，证书编号为J320020090005。 ？？2011年，江苏省商务厅换发对外劳务合作经营资格证书，证书编号为LW320020110003。 ？？2015年，成为中国对外工程承包协会理事会员。