Principal GSO Quality Parnter

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.

The Role

As we continue to grow as one QuidelOrtho we are seeking a Principal GSO Quality Partner, Product Health and Monitoring. The Principal GSO Quality Partner  is a global individual contributor within QuidelOrtho' s Global Quality & Compliance (GQ&C) organization. This individual is responsible to ensure the design, implementation, and continuous improvement of Quality systems, processes, and programs that enable QuidelOrtho' s Right to Operate and support business agility, innovation, and growth. This role provides strategic direction and operational oversight across Quality disciplines—including Quality Systems, Compliance, Design Assurance, Quality Engineering, and Quality Control—ensuring alignment with global regulatory requirements (ISO 13485, FDA 21 CFR 820, IVDR, and other applicable standards). The Principal GSO Quality Partner partners cross-functionally to embed Quality and Compliance principles throughout the product lifecycle, driving harmonization, inspection readiness, and continuous improvement. This individual is responsible for fostering a culture of engagement, collaboration, and performance with the Global Service Organization. By integrating technical expertise and data-driven insights, the Principal GSO Quality Partner ensures that Quality systems deliver sustainable business and compliance outcomes. 

This position will be onsite in Rochester, NY or San Diego, CA.

The Responsibilities

• Establish clear priorities, assign responsibilities, and ensure effective resource allocation to meet business and compliance needs. 

• Provide technical, regulatory, and operational leadership to ensure Quality systems comply with ISO 13485, FDA 21 CFR 820, IVDR, and other applicable requirements. 

• Drive harmonization and standardization of Quality processes, procedures, and tools across sites and functions to strengthen compliance and efficiency. 

• Primarily partners with the Global Service Organization in addition to Operations, R&D, Regulatory Affairs, and other stakeholders to integrate Quality and Compliance principles throughout the product lifecycle.  

• Promote a culture of continuous improvement by identifying opportunities for simplification, process excellence, and digital enablement within the Quality Management System (QMS). 

• Ensure the team maintains a state of inspection readiness and supports successful engagement with regulatory agencies, notified bodies, and internal audits. 

• Monitor Quality performance using metrics and data analytics to identify risks, drive root cause analysis, and implement sustainable improvements. 

• Coach and mentor emerging Quality team members to build organizational capability