北京招聘

*Guide and oversee design processes and document trail.

*Collaborate with R&D to build organizational capability and discipline in all areas pertinent to Design Controls of QMS *Develop quality plan and risk management plan for NPD as required.

*Ensure the DHF (Design History File) for new product is adequately maintained and complete each phase prior to product launch.

*Ensure all necessary compliance documentation is current and available upon request.

*Partners with other R&D leaders to revise and improve product development processes to drive efficiency, speed, and quality of outcome.

*Maintain and continuously improve Quality System to ensure compliance with ISO requirements through internal and external audit.

*Work closely with new product introduction teams to meet compliance requirements on schedule *Interface with corporate partners regarding design quality issues, audits, and special projects.

*Participate in project stage review and design review to ensure quality objective can be met through review design inputs and outputs. Escalate quality risk to management team

Minimum Qualifications:

*Expert of design controls of China GMP, CFR FDA820, ISO13485 and ISO9001 *Expert of risk management of ISO14971 *B.S. degree or higher in Engineering, Technology, or Science. Proficient in spoken and written English and Chinese languages.

*At least 5 years working in a regulated industry.

*Experience with product development process *Outstanding communication skills both in Chinese and English with capability to effectively communicate across different areas of functional expertise

website: www.uwuc.top

About UWU Consulting Co., ltd.
UWU Consulting is dedicating to solve the problems about talents that clients face to, to help clients with Human Resources integration and optimization, to provide clients consulting services as a think tank. Mainly, UWU Consulting is providing highly efficient cooperation in head-hunting with building long-term relationship with clients, and effective cooperation in RPO business and consulting services. Specialties areas: Medical instrument industry，Internet industry and also Consumer goods industry, manufacturing industry, Game industry etc. with clients of first-line brands in Europe and America, top 10 companies in China of the relative fields.

优吾企业管理咨询有限公司简介
优吾咨询是一家致力于企业人力资源发掘、整合及优化服务的猎头公司。为客户提供智囊式咨询服务，解决客户短期及中长期面对的人才问题，提供人力资源整体解决方案，在构建同客户长期、深入合作的关系的基础上，提供高效的猎聘合作。其中业务范围包括猎头,RPO及人力资源战略咨询服务等。精耕行业包括：医疗仪器行业、互联网行业以及消费品，制造业，物流和游戏．服务企业包括欧美一线品牌公司及本土排名前十的知名企业．

我们提供优厚的薪资福利待遇和资深顾问一对一的入职带教，欢迎善于学习，敢想敢为，对人力资源行业充满热忱的你加入我们团队！