Quality Assurance Manager
CorDxGeorgia, United States • Alpharetta, Georgia, United States
Posted September 22, 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
CorDx, a biotech organization focused on rapid testing and point-of-care medical devices, is seeking an experienced Quality Assurance Manager to lead its quality assurance team. The role involves developing, implementing, and maintaining Quality Management Systems, ensuring product quality and regulatory compliance, and leading a team focused on continuous improvement. The company emphasizes innovation and driving diagnostic solutions in healthcare.
Requirements
- Develop and implement Quality Management Systems (QMS).
- Lead internal and external audits, CAPAs.
- Oversee batch record reviews, deviations, and changes.
- Develop and enforce SOPs.
- Collaborate with R&D and regulatory affairs.
- Ensure adherence to GDP and data integrity policies.
- Lead the QA team and train manufacturing/quality teams.
- Monitor and analyze quality metrics.
Benefits
- Medical Insurance Plan
- Retirement Plan
- Paid Time Off
- Training & Development