Digital Informatics QMS Strategy Lead
QuidelOrthoNew Jersey, United States ā¢ Wales, United Kingdom ā¢ City of Rochester, New York, United States ā¢ San Diego, California, United States ā¢ New York, New York, United States
Posted February 21, 2026
155000 - 202000 USD
Full Time
About the Company
QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company.
Job Description
QuidelOrtho is seeking a Program Lead, Digital Informatics QMS Strategy, to develop and maintain the company's Quality Management System strategy for Digital Informatics, Software as a Medical Device, Artificial Intelligence, and Automation platforms. The role will be onsite in Rochester, NY.
Requirements
- 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.
- 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.
Benefits
- 401(k) plan
- Employee Stock Purchase Plan
- paid time off (including sick time)
- paid Holidays
- Medical, dental, vision, life, and disability insurance
