IMQ意美酷认证，意大利官方公告机构，招募无源医疗器械审核员

18917928662

医疗器械产品审核员（无源）
Key Responsibilities:主要职责：
Responsibilities and essential job functions includes but not limited to the following:
工作职责和职能包括但不限于以下：

• Execute Technical File assessments as a Product reviewer on NO-Active Medical Devices
• 作为无源医疗器械产品审核员审查客户技术文件；
• Contribute to the specific aspects relevant to your expertise, such clinical data, biocompatibility, sterilization, reprocessing etc during assessment;
• 在特定领域发挥自己的专业知识，如临床数据研究、生物相容性研究、灭菌验证、再处理等等。
• Responsible for the on-site audit, periodical Technical Files assessments, State of the art reviews and the Vigilance and Change Notifications of your customers;
• 负责客户的现场审查，定期技术文件审核，为客户定期和不定期进行法规和标准查新，识别风险。
• Maintain contact with the customer concerning the Product review outcome and required follow up;
• 与客户保持密切沟通，时刻关注产品审核结果和审核要求。
• Maintain contact with our Italian Headquarter colleagues, external experts and contractors;
• 与意大利总部团队、外部专家及第三方人员保持沟通
• Provide advise and mentoring to colleagues in the area of competence;
• 内部协助指导和培训员工。
• Provide the audit team with expert input and write test plans for unannounced audits;
• 为审核团队提供专业支持，为不通知的审核撰写测试计划。
• Will work at the company office      
• Skills:
• 技能：
• A PhD., MSc. or BSc. in a relevant product or medical area like Biomedical engineering, Medicine and relevant sciences;
• 在生物医学、药学或相关领域，拥有学士、硕士或博士学位
• A minimum of 4 years’ experience in the field of healthcare products or related activities, such as in manufacturing, auditing, assessment or research of which a minimum of 2 years shall be in design, manufacture, testing, conformity assessment or use of the No-Active medical devices or technologies to be assessed or related to the scientific aspects to be assessed;
• 至少4年医疗健康行业工作经验，如医疗生产/审核/评估/研究行业，其中，至少包含2年无源医疗器械设计/生产/测试/合规审核经验，或者审核范围内的无源医疗器械/技术使用经验。
• Experience with MDR and MDD;
• MDR和MDD经验
• Experience with ISO 13485 QMS;
• 有ISO 13485质量管理体系经验
• Experience with risk management according to ISO 14971;
• 有ISO 14971风险管理经验
• Experience with harmonized medical device standards on NO-active device熟悉无源医疗器械协调标准
• Experience on clinical data evaluation;
• 熟悉临床数据评估
• Experience as product assessor already qualified by Notified Body is an advantage;
• 拥有认证机构认可的产品审核员证书是加分项。
• Experience with other no-active device or related product is an advantage;
• 有其他无源医疗器械或相关产品审核经验是加分项。
• English language skills are required
• 英语需要能作为工作语言。
  

工作地点：上海市长宁区杨宅路258号