Digital Informatics QMS Strategy Lead

Overview

Quidel Ortho seeks a Program Lead in Digital Informatics QMS Strategy to develop and lead quality system strategy for digital health technologies across global markets. The role is based in Rochester, NY.

• Define and evolve the global QMS strategy for digital health technologies, including SaMD, AI/ML‑enabled systems, cloud‑based platforms, and automated workflows.
• Interpret and operationalize global regulatory and standards requirements such as FDA, EU MDR, IVDR, ISO 13485, IEC 62304, ISO 62366, ISO 14971, and 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 embed quality by design 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 risk‑based approaches for software lifecycle management, cybersecurity, data governance, AI/ML change control, and algorithm performance monitoring.
• Act as a thought leader and internal consultant on emerging regulatory expectations related to AI/ML, real‑world data, automation, and digital transformation.
• Perform other work‑related duties as assigned.

• Bachelor’s or technical degree in Life Sciences, Pharmacy, Engineering, Computer Science, Biomedical Engineering, or a related discipline.
• 8–10 years of progressively responsible experience within a regulated QMS environment with exposure to software, digital health, or informatics solutions.
• Demonstrated ability to lead QMS strategy development and influence senior stakeholders in 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 representing quality positions to executive leadership.
• Strong collaboration skills across technical, regulatory, and business functions.
• Willingness and ability to travel approximately 10–15%.

• Advanced degree such as MS, PhD, or Pharm
  
  D.
• 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.

• Manufacturing, laboratory, or warehouse setting with standard activities including sitting, standing, walking, and visual work.
• Optional travel for site visits, leadership meetings, or regulatory support.

Salary range: $155,000–$202,000 with bonus eligibility. Benefits include medical, dental, vision, life, disability insurance; 401(k) plan; employee assistance program;
Employee Stock Purchase Plan; paid time off, sick time, and paid holidays.

Quidel Ortho is an equal opportunity employer and provides reasonable accommodations to qualified individuals. All individuals, including those with disabilities, are encouraged to apply without regard to protected characteristics.