Sr. Manager, Design Quality HW & Software

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, Design Quality (Hardware & Software). The Sr. Manager, Design Quality (Hardware & Software) 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 Design 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.

This role leads a team of quality professionals that provide strategic direction and operational oversight across product design lifecycle with responsibility for overseeing Design Controls and Risk Management for hardware, software, and integrated IVD systems. The team also ensures that user needs, requirements and claims are translated into testable scientifically sound criteria. As the primary Quality partner for cross functional development teams, this role also guides the evaluation and approval of design changes, drives validation and claim verification strategies, and represents Quality in global audits.

This role is responsible for ensuring alignment with global regulatory requirements (ISO 13485, FDA 21 CFR 820, IVDR, and other applicable standards). This position requires a blend of technical expertise, leadership capability, and the ability to navigate complex, fast paced environments while championing a proactive quality culture. The Quality & Compliance Manager/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 Sr Manager, Design Quality (Hardware & Software) ensures that Quality systems and teams 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 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 R&D, Regulatory Affairs, Manufacturing, 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…