通用电气(中国)有限公司(医疗集团--GE China-Healthcare)<br>质量体系专员Product Surveillance Specialist<br>
基本职能(职责)<br>作为客户抱怨处理团队成员,此职位需要:<br>-组织由多个职能部门参加的客户抱怨的初始评审和关闭评审。与安全法规专员、临床应用专员和设计工程师密切合作,进行有效的评审和抱怨处理;<br>-驱动客户抱怨流程的实施,包括筛除重复和非客户抱怨,保证每个抱怨被评估,需要调查时有负责人,低影响的抱怨关闭留作趋势分析;<br>-确保抱怨处理系统中记录的完整和准确,将抱怨处理中的各种活动记录存档,从记录产生、风险/重要性评估、是否需要报告,到调查、纠正预防措施计划的制定和实施、直至最终关闭。<br>-每周报告客户抱怨的进展,每月定期分析抱怨数据并作出趋势报告。<br>-每周评审维修团队的所有计划外维修纪录,并据此作趋势报告。<br>-为外部或公司内部的审计、检查和汇报提供数据和支持。<br><br>所需技能:<br>沟通能力 – 能熟练运用英语与本地和全球团队进行口头和书面沟通。<br><br>协调和领导力 – 有能力组织多职能部门参与的讨论,并在其中起协调作用,帮助大家就发现的问题达成一致、找到解决办法。<br><br>自我激励和注重细节 – 能激励自己,认真达到工作目标,主动思考和寻找对现有工作流程和机制的改进方法。<br><br>质量意识 – 理解质量体系和要求的价值和重要性,对流程的运行实施和增进其一致性的活动富有激情。<br><br>所需资格/必要条件<br>理、工、医科学士或硕士毕业。必须有良好的英文听、说、读、写能力。<br><br>能熟练使用Microsoft Excel和PowerPoint做数据分析和图表制做编辑。<br><br>有以下条件者优先考虑<br>具有X-ray产品设计、生产或维修服务、或质量控制经验。<br><br>具备较强的客户服务和产品质量意识,和流程改进意识。<br><br>具备良好的逻辑分析、与人交流能力和分析与解决复杂问题的能力。<br>Essential Functions (responsibilities)<br>As a member of complaint handling team, PSS will<br>Organize and coordinate complaint incoming and closure reviews with cross-functional teams. Integrate with regulatory affairs specialists, clinical specialists and design engineers to conduct effective reviews and complaint handling.<br>Drive process compliance per complaint handling work instruction: screen out duplicate and non-complaints, ensure each complaint is assessed and assigned an active owner if investigation is needed, and close low impact ones to trending. <br>Ensure the accuracy and completeness of complaint records in complaint handling system, document complaint handling activities starting from record creation, hazard/impact evaluation and reporting decision if applicable, investigation, action plan making and execution to final closure.<br>Report complaint status on a weekly basis, analyze complaint data with the rest of team on a monthly basis and draft trending reports.<br>Review service records as they are received according to work instruction, and analyze these data in trending report.<br>Provide support during inspections, audits, and report-outs as necessary.<br><br>Key Skills: <br>Communication – both oral and written, in English and Chinese, with local and global members. <br><br>Coordination and facilitation – be able to facilitate review meetings with cross-functional teams and drive agreement for issues identified.<br><br>Motivation and attentiveness to details – self-motivated, strong ownership to deliver to commitment, proactively looking for ways to improve and optimize current processes and mechanisms.<br><br>Quality mindset – understand the value and importance of quality, strong desire to drive process compliance and consistency.<br><br>Qualifications/Requirements<br>Bachelor degree in science, engineering, or medicine. <br><br>Must demonstrate proficiency with Microsoft Excel and PowerPoint software. Fluency in English comprehension, reading and writing. <br><br>Desired<br>Experience in engineering, manufacturing and service operations or quality functions in medical device industry especially X-ray or MRI is a plus.<br><br>Strong process improvement mindset, passion for quality and customer focus. Good interpersonal skills, strong analytical skills, and the ability to solve complex problems.</p>
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