职位描述

What are my responsibilities? Project/product : Ensure project management and process control complying with internal regulation, ensure products' compliance with quality requirements. Support and consult for project and process quality control. Join the reviews for the decisions of milestones. Monitor the product regulatory compliance. Tasks: Assist Quality manager to implement Quality Management System in design and manufacturing process. Familiar with process who can interprete and provide consultant on process implementation. Provide the solution for process issue during development phase to make sure process compliance. Work closely with project team and participate in the review and evaluation on relevant documentation coming from different stage of PEP. Monitor key quality process implemented on specific products who is responsible for such as complaint handling process, engineering change process, reportable MDR process, risk management process, and CAPA process, etc. Monitor manufacturing quality, initiate data analysis and corrective & preventive actions if necessary. Support internal audit and external audit. Reporting and escalation any deficiencies, do the statistics for tracking the product KPIs who is responsible for. Responsible for process optimization and quality template optimization related to project control and process control. Act as quality contact window required in the quality agreement with customer. Act as an independent quality function to review development and manufacturing documents. What do I need to qualify for this position? Experience with project quality management and process quality control and supplier quality control Experience with quality control for new product development project from design concept(D1)to mass production release (D4) Strong knowledge for ISO13485, MDD and 21CFR Part 820, ect. Bachelor above, medical device product knowledge Good English 3 - 5 years experience on medical device field提醒： 　　点击“西门子专属申请”，您将会进入西门子专属招聘系统，进入系统后您可以在页面右上方的下拉菜单，选择简体中文页面，并请遵循下面的规则设置您的系统密码。 　　密码设置规则：密码长度必须在8个字符以上，并且必须包含英文大写字母，小写字母和数字。例如：Ab123456 职能类别： 医疗器械市场推广 其他

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