Quality Lead, Requirements and Specifications Management (Assay)

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 Quality Lead, Requirements and Specifications Management (Assay). The Quality Lead, Requirements and Specifications Management (Assay) 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 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.‑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, 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 requirements‑matter 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. 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. 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 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 and ensure robust succession planning. Communicate Quality and Compliance strategy, progress, and risk mitigation plans to senior leadership and cross-functional stakeholders. Perform other work-related duties as assigned. The Individual Required: Bachelor’s degree in Life Sciences, Engineering, or a related technical discipline. 7+ years of progressive experience in Quality, Compliance, or related fields within the Medical Device, IVD, or Biopharmaceutical industries. Strong understanding of Quality System regulations and standards, including ISO 13485, FDA 21 CFR 820, and IVDR. Demonstrated success driving Quality and Compliance initiatives that align with business strategy and regulatory expectations. Excellent collaboration, influence, and communication skills across func