Senior Manager Quality Engineering Excellence

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 Senior Manager Quality Engineering Excellence. The Quality Engineering Excellence Senior Manager is a global people leader within Quidel Ortho’s Global Quality & Compliance (GQ&C) organization. This leader is 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’s Right to Operate and support business agility, innovation, and growth.

The position leads global quality engineering activities that support the manufacture, testing and release of in vitro diagnostic medical devices.

This role is accountable for ensuring consistent, compliant, and efficient operational quality execution across global manufacturing sites. Focusing on manufacturing quality engineering, process robustness, nonconformance management, and continuous improvement (CAPA), ensuring compliance with global regulatory requirements while supporting operational excellence and supply continuity.

This role provides strategic direction and operational oversight across Quality Engineering ensuring alignment with global regulatory requirements (ISO 13485, FDA 21 CFR 820, IVDR, and other applicable standards). The Senior Manager partners cross‑functionally to embed Quality and Compliance principles throughout the product lifecycle, driving harmonization, inspection readiness, and continuous improvement.

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 Quality & Compliance Senior Manager ensures that Quality systems 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 Operational Quality Engineering processes, procedures, and tools across sites and functions to strengthen compliance and efficiency.
• Implementation of standardized NC/CAPA processes to drive robust risk management, CAPA effectiveness and continuous improvement. Ensure effective management of nonconformances, deviations, and rework activities using structured root cause analysis methodologies.
• Assess and mitigate quality risks associated with process, equipment and material. Ensure quality engineering support for manufacturing changes and compliant execution of change controls and validation activities. Driving harmonized, efficient, validation strategies for equipment, process and facilities.
• Partner with Manufacturing, R&D, Regulatory Affairs, Supply Chain, and other stakeholders to integrate Quality and Compliance principles throughout the product lifecycle.
• Promote a culture of continuous improvement by identifying…