Senior QA Manager
CorDxAtlanta, Georgia, United States
Posted May 12, 2025
Full Time
About the Company
CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare. #Biotechnology #Pharmaceuticals #Diagnostics #Healthcare #PersonalisedHealthcare #GreatPlaceToWork #Innovation
Job Description
CorDxa is seeking a Senior QA Manager to lead and supervise the QA team, ensuring the implementation and maintenance of the company's Quality Management System. The role involves cross-functional collaboration, regulatory compliance, process improvement, and audit participation. The company delivers rapid testing and point-of-care medical devices in the COVID-19 and other healthcare areas.
Requirements
- Bachelor’s degree in a scientific, engineering, or related technical discipline
- 7+ years of progressive QA experience
- Minimum of 3 years in a QA leadership or management role
- Hands-on experience in manufacturing and product quality oversight
- Working knowledge of FDA 21 CFR Part 820, ISO 13485, and other applicable international quality standards
- Experience supporting regulatory audits, product inspections, and submissions (preferred)
Benefits
- Highly competitive compensation package
- Comprehensive medical, dental, and vision insurance
- 401(k) plan
- Flexible paid time off (PTO)
