职位详情
五险一金
绩效奖金
全勤奖
节日礼物
年度旅游
交通补助
工作职责:
1、根据国家各项医疗器械的法律、法规和公司的战略目标，主持制定公司的质量方针、质量目标，组织质量目标分解并监督执行；
2、推进质量管理体系建设，依据公司质量方针、战略目标组织公司质量管理体系的运行；
3、组织贯彻、执行医疗器械行业相关监管法规、医疗器械行业相关质量管理标准，以符合法规的要求；
4、制定并组织实施企业质量管理体系的审核计划，协助企业负责人按计划组织管理评审，编制审核报告并向企业管理层报告评审结果；
5、负责产品质量策划，推进质量风险评估和风险控制措施的实施，监督实施过程；
6、在生产企业接受各级药品监督管理部门监督检查时，与检查组保持沟通，提供相关信息、资料，配合检查工作；针对检查发现的问题，组织企业相关部门按照要求及时整改；
7、负责质量内部审核，监督公司内部各部门质量管理体系运行情况，以保证各部门各项工作的顺利开展。
任职资格:
1、 专科及以上学历，医疗器械相关专业（医疗器械、生物工程、医学、机械、材料、机电、自动化类等）；英语能力良好；
2、具有3年以上医疗器械质量管理工作经验，熟悉产品、生产和质量管理情况；
3、熟悉医疗器械注册人制度；
4、熟悉ISO9001 、ISO13485质量管理体系，熟悉医疗器械法规，了解相关体系，熟悉相关行业内的管理模式；
5、熟悉医疗器械产品法规或质量管理标准（如：GMP、FDA、MDR法规等）；
6、有较好的体系文件和检验文件编辑能力；
7、具备优秀的领导能力、组织、沟通、协调能力、分析解决问题能力，严谨、务实、责任心强
其他信息
行业要求：全部行业
公司介绍
Founded in 1964, only four years after the invention of the very first laser, Fotona is one of the most experienced developers of high-technology laser systems, recognized for the design, manufacture, and support of advanced solid-state laser systems for:
medicine (aesthetics, surgery, gynecology),
dentistry,
industry & defense
Choose Fotona – Choose Perfection
Fotona is fully committed to stringent testing of all components and in-house production of its medical and dental laser systems. This long-term dedication to perfection ensures that the company's laser systems are of the highest quality, reliability and durability.
Excellence in Training and Support
By establishing the Laser and Health Academy*, Fotona has partnered with world-leading clinical experts to provide medical practitioners with a platform for continuing their professional growth. Fotona customers receive access to professional workshops, individual training sessions, hands-on demonstrations, as well as participation in international clinical studies and international scientific symposiums. Fotona is also a founding member of the EU Competency Center for Biomedical Engineering, and of the EU technology platform Fotonika21.
When you choose Fotona, you choose a company committed to designing, manufacturing and delivering:
The highest performance, best made laser systems in the world
