上海马尔斯企业管理咨询有限公司<br>LSS V&V Leader麻醉呼吸机事业部<br>The V&V Leader will be responsible of V&V team in engineering department of LSS iPerfromance, the team will be response for the development test requirement and plan for new/updated products, and the implementation effort on various verification & validation activities in different engineering projects. This position will also provide technical guidance to members of the team. <br><br>Key responsibilities/essential functions include:<br>· Build up V&V team & competence for Anesthesia machine development, which includes mechanical, electrical and software verification & validation.<br>· Develop testing/verification requirements and plans for product design on both new & existing product.<br>· Executes test/verification & validation procedures<br>· Offers suggestions to refine and automate test procedures<br>· Perform test plan reviews<br>· Prioritize and schedule testing<br>· Support product development teams and provide need pre-qualification and verification testing<br>· Support the qualification of lab area productivity improvement efforts, including testing, building fixtures, calibration and data collection.<br>· Provide knowledge of test equipment set-up, functional operation, and interconnect of related equipment.<br>· Review necessary support documentation and maintain documentation for each test in a neat and organized fashion.<br>· Developing reporting systems to generate collateral that documents evidence of quality development processes<br><br>Quality Specific Goals:<br>1. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position<br>2. Complete all planned Quality & Compliance training within the defined deadlines<br>3. Identify and report any quality or compliance concerns and take immediate corrective action as required<br>4. Ensure compliance/closure of Regulatory and Quality requirements before approving Design Outputs/Program Deliverables<br>5. Lead continuous improvement activities by driving the implementation of process and product quality improvement initiatives<br><br>Required Qualifications: <br>1. At least Bachelor's Degree in Mechanical engineering, Electrical Engineering or Industrial Engineering.<br><br>2. 5+ year experience in an engineering field, including 2+ years of experience as a Product or Test Engineer.<br>3. In-depth understanding of qualification equipment, test procedures and industry requirements, such as IEC 60601-1.( IEC认证解释:IEC标准即国际电工委员会(International Electrical Commission),是由各国电工委员会组成的世界性标准化组织,其目的是为了促进世界电工电子领域的标准化。<br>IEC的宗旨是通过其成员,促进电气化、电子工程领域的标准化和有关方面的国际合作,例如根据标准进行合格评定的工作,电气、电子和相关技术方面的合作等。)<br>4. A strong management & leadership Skill for leading the V&V team & a strong interpersonal skill set, including good technical communications. <br>5. Previous project or team leadership experience. <br>6. 2+ years development experience with Relational Database (MS SQL Server preferred)<br><br>Preferred Qualifications:<br>1. Experience with statistical data analysis tools<br>2. Ability to write reports and procedure manuals, and to effectively present information and respond to questions from managers and engineers.<br>3. Experience in developing test tools to improve productivity of test script development and execution.<br>4. Previous supervisory experience, including global and/or virtual team<br>5. Experience in a health-care related field. <br>Experience in a regulated environment, e.g. SFDA, FDA, etc ( 国家食品药品监督管理局的英文缩写(state food and drug administration)。 FDA的意思是“食品药品管理局”,未标明国家名称的一般是指美国食品药品管理局)不限面议上海市宁夏路201号绿地科创大厦2楼D座
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柯惠医疗器材制造(上海)有限公司<br>质量检验员 Quality Inspector<br>- Records defects and failure rates.<br>- Initiating action to prevent the occurrence of product non-conformity.<br>- Identifying and recording any quality system problems.<br>- Reviewing the Quality Management System at designated intervals to determine its continued effectiveness and, where appropriate, making changes for improvement.<br>不限面议上海市闵行区浦星路789号10号楼
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