Digital Informatics QMS Strategy Lead

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 Program Lead, Digital Informatics QMS Strategy. This Program Lead is responsible for developing, maintaining, and communicating Quidel Ortho' s Quality Management System strategy for Digital Informatics, Software as a Medical Device (SaMD), Artificial Intelligence (AI/ML), and Automation platforms as they pertain to in vitro diagnostic (IVD) products and associated services across all global markets.

This role serves as the strategic quality authority for digital enabled products, ensuring that regulatory, quality, and compliance expectations are proactively embedded into product lifecycle processes, digital delivery models, and organizational ways of working.

This position will be onsite in Rochester, NY.

• Define and evolve the global QMS strategy for digital health technologies, including SaMD, AI/MLenabled systems, cloud based platforms, and automated workflows.

• Interpret and operationalize global regulatory and standards requirements (e.g., FDA, EU MDR/IVDR, ISO 13485, IEC 62304, ISO 62366, ISO 14971, GxP data integrity) as they apply to digital and informatics solutions.

• Partner with R&D, IT, Product Management, Regulatory Affairs, PMO, and Technical Quality to ensure quality by design is embedded throughout the digital product lifecycle.

• Establish governance models, procedural frameworks, and decision pathways that enable agile and scalable digital innovation while maintaining regulatory compliance.

• Lead riskbased approaches for software lifecycle management, cybersecurity, data governance, AI/ML change control, and algorithm performance monitoring.

• Serve as a thought leader and internal consultant on emerging regulatory expectations related to AI/ML, realworld data, automation, and digital transformation.

• Perform other work-related duties as assigned.

Required:

• Bachelors and/or technical degree in Life Sciences, Pharmacy, Engineering, Computer Science, Biomedical Engineering or a related technical discipline.

• 8-10 years of progressively responsible experience within a regulated Quality Management System environment, with significant exposure to software, digital health, or informatics solutions.

• Demonstrated ability to lead QMS strategy development and influence senior stakeholders across complex, matrixed organizations.

• Strong understanding of global regulatory frameworks applicable to digital health, SaMD, AI/ML, and automated systems.

• Proven experience applying risk management, design controls, software lifecycle processes, and post market surveillance to digital products.

• Ability to translate regulatory and quality requirements into practical, scalable processes that support innovation.

• Bias toward action, with a track record of driving execution aligned to organizational strategy.

• Excellent written and verbal communication skills, including the ability to represent quality positions to executive leadership.

• Strong collaboration skills and the ability to operate effectively across technical, regulatory, and business functions.

• Willingness and ability to travel approximately 10-15%.

Preferred:

• Advanced degree (MS, PhD, or Pharm
  
  D) strongly preferred.

• Experience with AI/ML governance, algorithm change management, or real-world performance monitoring.

• Background in cloud based systems, cybersecurity, data integrity, or regulated automation platforms.

• Experience supporting global regulatory inspections involving software or digital health products.

Internal:
Operations, Supply Chain, R&D, Commercial, Regulatory Affairs, GSO, Quality & Compliance teams globally and regionally.

External:
Regulatory agencies, Notified Bodies, Contract manufacturers, Suppliers, and service providers.

The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment.

No strenuous physical activity. Standard activities include sitting, standing, walking, talking, hearing, and visual work. May include occasional travel for site visits, leadership meetings, or regulatory support.

At Quidel Ortho, our culture is shaped by four core behaviors that guide how…