审核员(上海/北京/深圳)

该职位来源于猎聘 1.医疗器械、生物医学、生物工程、化学工程、机械工程、材料和冶金工程、工业工程、物理、化学、生物、医学、牙科学、药学等相关专业本科(学士)及以上学历; 2.至少拥有以下一项4年及以上工作经验; 2.1.医疗器械工业或相关工业(例如制药),从事研发、测试、制造、质量管理、法规事务等工作,具备灭菌工作经验者优先。 2.2.医疗机构、高校、基金会或其他机构,从事检验、审核、临床评价、试验和/或临床研究等工作,具备医师资格、中国CCAA注册审核员资质、欧盟公告机构审核员工作经验者优先。 3.具备13485质量管理体系和欧盟医疗器械法规MDR认证专业知识,熟悉相关法规、标准、指南要求。 4.具备良好的沟通表达技巧,中英双语听说读写能力,毕业于英语授课大学或有国际认可语言能力证书者优先。 5.能适应国内外出差,具备客户服务精神、团队合作精神以及高度责任心,严格遵守审核员行为准则,保持客观性和公正性以及履行保密义务,抗压能力强,时间管理高效。 职位介绍: 1.根据公司安排的审核任务,策划、实施审核并完成相关报告,及时向相关方反馈审核过程中出现的各种问题并积极配合解决; 2.参加公司安排的相关培训,为市场活动提供技术支持; Job Requirements:

• A bachelor's degree or above in relevant majors such as medical devices, biomedical, bioengineering, chemical engineering, mechanical engineering, materials and metallurgy engineering, industrial engineering, physics, chemistry, biology, medicine, dentistry, pharmacy, etc.
• Have at least 4 years' experience in one of the following areas: 2.
• Work in medical devices industry or closely related industries (e.g., pharmaceutical industry) such as research and development, testing, manufacturing, quality management, regulatory affairs. Those with sterilization work experience are preferred. 2.
• Work in health services, universities, foundations or other institutions carrying out inspections, audits, clinical evaluations, experimental and/or clinical research. Those with clinician qualifications, Chinese CCAA registered auditor qualifications, and work experience as an auditor in EU Notified Bodies are preferred.
• Have professional knowledge of the 13485 QMS and EU MDR certification, and be familiar with relevant regulations, standards, and guidance.
• Have good communication and presentation skills, and be proficient in both English and Chinese in listening, speaking, reading, and writing. Graduation from English-speaking university or those English proficiency certificates from internationally recognized language exam are preferred.
• Be able to adapt to domestic and international business travels, have a spirit of customer service, teamwork spirit, and a high sense of responsibility. Strictly abide by the auditor's code of conduct, maintain objectivity and fairness, and fulfill confidentiality obligations. Have strong stress - resistance ability and efficient time management skills. Job Description:
• According to the audit tasks arranged by the company, plan and perform audits, and complete related reports. Timely feedback various problems that occur during the audit process to relevant parties and actively cooperate to solve them.
• Participate in relevant training arranged by the company and provide technical support for marketing activities.
• Keep track of the latest developments in regulations, standards, and guidance, and cooperate with relevant work arranged by the company. 3.跟踪法规标准指南的最新动态,配合公司安排的相关工作。