Job Descriptions:
85 该职位负责新工厂的试剂研发的设计质量管理，全面随同研发部参与试剂的设计开发，确保设计过程符合公司产品开发和设计质量控制体系和销售国法规对研发的要求。
This Position will create and maintain the Design Quality Control for Assay in new facility, work with R&D to involve in the design and development activities, to ensure the QuidelOrtho Product are developed in compliance with the company Product Development & Design Quality Systems and worldwide Design Control Regulations.
85 针对试剂研发起草或更新和维护现有设计控制流程以确保符合总部最新设计开发流程要求
create or update and maintain the current design control process for Assay to consistent with latest global Design control process,
85 根据项目策划参与研发过程，确保研发过程符合公司设计开发和GMP要求，包括协调设计变更和设计评审管理, 确保设计输出和输入的可追溯性，设计审核等等。
work together with R&D to involved in R&D activities accordingly the project plan, ensure the compliance with company Design control and GMP requirement, include coordinate the design change and design review, ensure the traceability matrix for design input and output, design audit etc.
85 管理和归档DHF， 确保设计输出和输入的可追溯性，Manage and archive the DHF, coordinate the design risk management and pFMEA..
85 支持设计设计到生产的转移，包括起草主验证和确认计划，实施过程确认，产品设计验证等。
support the design transfer to manufacturing, include create the Master Verification and Validation plan, implement process validation, product design verification accordingly.
85 支持整个质量体系的建设，包括参与内审，NC， CAPA， 培训等。
support the whole quality system establishment, include implement the internal audit, NC, CAPA and quality training

Required Qualifications:
85 制药、化学、生物相关专业大学本科以上学历
Pharm. Chemistry, Biology related major, bachelor or above
85 5年以上产品质量管理经验，至少3年以上研发质量相关工作经验，熟悉设计开发质量控制，设计变更、风险管理、设计评审。
at least 5 Years working experience in product quality management, with at least 3 year direct design control experience in Assay development, professional for Design control process, include design change, risk management, design review.
85 5%国内和国际差旅(总部，供应商和商业开发合作伙伴)
5% Domestic & International travel (interactions with global，Suppliers/ Business Development partners