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.

PHYSICAL DEMANDS

A job description should include physical demands that are essential to the job’s performance to comply with the American with Disabilities Act (ADA). Physical demands are the level and duration of physical exertion needed to perform critical tasks, such as:

sitting, standing, walking, lifting, carrying, reaching, pushing, and pulling. Other physical demands include:

• Bending
• Crawling
• Stooping
• Vision
• Climbing or balancing
• Kneeling
• Crouching
• Talking or hearing
• Tasting or smelling

THE ROLE

As we continue to grow as QuidelOrtho, we are seeking a Lead for Instrument Verification and Validation to help with formal verification and validation of complex medical devices under the regulations of the FDA. The individual will lead and be part of an engineering team that is responsible for requirements-based manual test case design and execution of test procedures in a BL2 lab environment. The team is highly collaborative and will require regular interactions in formal reviews, test planning activities, and working with software development and partners to reproduce and verify system defects.
The job is 100% onsite at 100 Indigo Creek Drive (CNP location).

THE RESPONSIBILITIES

• Manage V&V resources with testing and debugging system software, serving as a technical bridge between software Development and V&V
• Ensures rigorous adherence to design control documentation and internal procedures for post-launch activities, maintaining regulatory compliance and product quality standards
• The development of requirements-based manual test procedures
• Compilation and analysis of test results
• Documentation and management of system software defects
• Lead in regular scheduling, planning, resourcing, and team meetings
• Participate in regular off-hour meetings with the business partner
• Understand project goals and timelines, and provide technical leadership to ensure product launch success
• Ensures optimal resource allocation and timely project completion while maintaining quality standards
• Provides critical oversight in resolving field issues and maintaining product integrity throughout the lifecycle
• Mentor and develop team members to help them grow professionally
• Perform other work-related duties as assigned.