Director, Field Actions and Reporting

The Opportunity

Quidel Ortho 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.

As we continue to grow as one Quidel Ortho we are seeking a Director, Field Actions and Reporting. The Field Action and Reporting Directorisaglobal people leader within

Quidel

Ortho' sGlobal Quality & Compliance (GQ&C) organization. This leaderis responsible for developing and leading a team of Quality professionals to ensure the design, implementation, and continuous improvement of Quality systems, processes, and programs that enable

Quidel

Ortho' sRight to Operate and support business agility, innovation, and growth.

This position provides strategic direction and operational oversight across

Quidel

Ortho' sField Action and Reporting activities ensuring alignment with global regulatory requirements (ISO 13485, FDA 21 CFR 820, IVDR, and other applicable standards). The role partners cross-functionally to embed Quality and Compliance principles throughout the product lifecycle, driving harmonization,inspection readiness, and continuous improvement.

The role leads the strategy and execution for field action and reporting activities across the globe. The responsibilities span all quality elements associated with field actions and regulatory reporting activities andincludesthe oversight of the Safety, Recall and Regulatory Reporting processes. This role also demands identification and execution of continuous improvements toQuidel

Ortho' sProduct Health and Monitoring processes at the global level to meet the current and future needs of theQuidel

Orthobusiness. These improvements will ensure continued compliance with quality system regulations while driving overallefficienciesand improvements inQuidel

Ortho' sProduct Health and Monitoring Processes. These initiatives will demand close collaboration with key stakeholders and business partners across the organization including but not limited to Global Service Organization, Regulatory, Operations, R&D, Site Quality, Design Quality, Global Compliance and Regulatory. This leader is also accountable for developing talent, strengthening scientific and compliance capabilities, and fostering a culture of engagement, collaboration, and performance.

By integrating technical expertise, data-driven insights, and agile leadership behaviors, the Field Action and Reporting Directorensuresthat Quality System and teams deliver sustainable business and compliance outcomes.

This position will be onsite in Rochester, NY.

• Lead, develop, and inspire a team of Quality professionals to achieve organizational and individual performance objectives.

• 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.

• Partner with Operations, R&D, Regulatory Affairs, Global Service Organization, Commercial 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…