Senior Quality Engineer

The Opportunity

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic.

Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

This position is mainly for the product quality management, provides quality oversight for the development and commercialization of new Assay and instrument products in addition to design transfer and post commercialization change management, NC, PMS etc..

该职位主要针对产品质量管理，针对产品设计开发和商业化试剂和设备产品的全面质量管理，包括参与研发产品的设计转移和上市后产品的变更、产品不符合、后市场监管等。

The role will ensure that Ortho instrument products are developed in compliance with Ortho Product Delivery & Quality Systems and worldwide Design Control Regulations.

该职位将确保奥森多设备产品的开发符合奥森多全球研发和设计控制相关要求。

The position will also partner closely with R&D and Product Lifecycle Management teams, entrusted manufacturing site to ensure a risk-based product management while ensuring continued compliance with global Quality System Regulations. Key outputs include: documentation to support efficient worldwide regulatory submissions, product risk management, and comprehensive design history file review, change management.

该职位将跟研发和产品生命周期管理团队、外部生产商紧密合作确保基于风险的产品管理，确保持续的符合总部质量体系要求。主要包括法规注册支持，产品风险管理，强化设计历史文件评审，变更管理等。

Maintain the established local quality system, work with global R&D and quality, provides Design Control / Design Change Control guidance to external product development teams, including risk management and DHF maintenance.  Ensures effective partnering and collaboration with Product Development, Quality Operations, Regulatory Affairs and Operations to meet project goals, maintain compliance, and complete defined regulatory submissions.

维护建立的本地质量体系，同总部研发和质量一起，向外部产品研发团队提供设计控制/设计变更控制指导，包括风险管理和设计开发文档管理。确保同产品开发、质量运营、法规事务和运营团队的有效合作和协助，确保满足项目目标、维护合规和完成确定的产品注册

Partners with the R&D and Product Lifecycle Management teams ensuring a risk-based approach to the validation and implementation of product changes to existing commercial product while maintaining compliance with global Quality System elements, including but not limited to: Design Control, Design Change, Risk Management and Change Control. Provides Quality Oversight to Business Field Technical teams related to non-conformance, root cause investigations and CAPA.

协同研发和产品生命周期管理团队确保对于现有商业化产品的验证和产品变更基于风险，同时确保始终符合全球质量体系要素，包括但是不限于：设计控制、设计变更、风险管理和设计控制。给与区域技术团队提供基于不符合管理、根本原因调查和纠正预防措施的全面质量监管。

Work with global CHU and manufacturing site for complaint handling process and AE reporting

协同总部投诉处理中心和生产工厂进行投诉处理和不良事件上报。

Maintain the current QMS and ISO certificate, based on current QMS, support all QuidelOrtho product design and manufacturing project, include but not limited for supplier and material management, product nonconforming.

维护质量管理体系和ISO证书，基于现有的质量管理体系，支持奥森多所有产品开发和生产项目，包括但是不限于供应商管理、物料管理、产品不合格等

Collaborates with other QRC groups, R&D, and Operations to ensure successful external Inspections

协同其他QRC团队、研发、和运营团队确保通过所有的外部审核.