北京招聘

Responsibilities:
1. Understand and deploy processes to assure conformance to government regulations, industry standards and product specifications.
2. Review and approve process validation protocol and production related procedure
3. Review environmental conditions records and respond to excursions
4. Work with Production Dept. to monitor production processes and resolve production quality issues.
5. Investigate, assess and close deviations, determine impact of the issues that could affect product quality, safety and effectiveness.
6. Work with Production, Regulatory Affairs, Marketing, New Product Development and other necessary departments to maintain awareness of Quality Operation activities.
7. Work out Quality system , deploy Quality systems (e.g. CAPA, process control) to ensure products conform to defined requirements.

Experience:
1. At least 5 years work experience in quality filed,
2. At least 3 yrs. work experience in medical device industry or high regulated industry.
Competencies and skills:
1. Strong understanding of Quality System regulations ( ISO9001， ISO13485, QSR, GMP).
2. Good understanding of statistical methods, quality tools and methodologies (SPC, FMEA, DOE, etc.)
3. Well-developed organizational and analytical skills
4. Proven ability to understand and identify relationships and interdependencies across multiple projects
5. Communicate globally, across teams and programs, from senior executives to administrative support personnel.
6. Both detail oriented and able to see big picture
7. Good command of English is a MUST.

    我公司主营医疗器械销售，研发，医疗器械技术咨询与技术服务，主要经营设备种类：德国进口内窥镜，医疗美容激光，泌尿外科高值耗材。我公司始终坚持“质量第一、客户至上”的经营理念；凭借高质量的产品、专业化的团队、完善的售前、售后及技术服务体系，赢得了市场的良好口碑。公司尊崇“踏实、拼搏、责任”的企业精神，并以诚信、共赢、开创经营理念，创造良好的企业环境，以全新的管理模式，完善的技术，周到的服务，卓越的品质为生存根本，我们始终坚持用户至上，用心服务于客户，坚持用自己的服务去打动客户。