Global Quality Lead - Assay & Specs

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 Quality Lead, Requirements and Specifications Management (Assay). The Quality Lead, Requirements and Specifications Management (Assay) is a global individual contributor within Quidel Ortho' 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 Quidel Ortho' s Right to Operate and support business agility, innovation, and growth.

This role provides strategic direction and operational oversight across product lifecycle quality with responsibility for defining, owning, and continuously improving the end to end requirements and specifications framework for a portfolio of assay based medical device products. This role establishes standardized processes, templates, and best practices that ensure product, system, and manufacturing requirements are clear, traceable, compliant, and fit for purpose across the entire product lifecycle.

The Quality Lead works cross-functionally to embed Quality and Compliance principles throughout the product lifecycle.

This individual acts as the subject matter authority for requirements and specifications-partnering closely with R&D, Systems Engineering, Design Quality, Regulatory Affairs, Manufacturing, and Product Management to ensure robust design inputs that enable compliant, scalable, and high quality product development. This role is responsible for the governance, definition, and continuous improvement of the organization's assay requirements and specifications of management processes. This role functions as the enterprise subject matter expert and process owner, leading through influence, expertise, and accountability rather than people management.toend

requirements and specifications framework for a portfolio of assaybased medical device products. This role establishes standardized processes, templates, and best practices that ensure product, system, and manufacturing requirements are clear, traceable, compliant, and fit for purpose across the entire product lifecycle.

The Quality Lead works cross-functionally to embed Quality and Compliance principles throughout the product lifecycle, driving This individual acts as the subject matter authority for requirements and specifications-partnering closely with R&D, Systems Engineering, Design Quality, Regulatory Affairs, Manufacturing, and Product Management to ensure robust design inputs that enable compliant, scalable, and quality product development. This role is responsible for the governance, definition, and continuous improvement of the organization's assay requirementsmatter expert and process owner, leading through influence, expertise, and accountability rather than people management.

This individual is responsible for fostering a culture of engagement, collaboration, and performance. By integrating technical expertise and data-driven insights, the Quality Lead ensures that Quality systems deliver sustainable business and compliance outcomes.

This position will be onsite in Rochester, NY.

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

• Provide technical, regulatory, and operational leadership to…