Quality Assurance Manager
2 days ago
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OnsiteFull-timeSenior
Summary
CorDx is seeking a Quality Assurance Manager to join their team in Alpharetta, GA. The role involves leading the quality assurance team in the development, manufacturing, and distribution of Class II IVD devices.
About the Role
As a Quality Assurance Manager, you will be responsible for developing and maintaining Quality Management Systems (QMS) in compliance with US FDA and ISO 13485 regulations. You will lead audits, oversee batch record reviews, and ensure product quality through collaboration with R&D and production teams. Additionally, you will mentor the QA team, drive continuous improvement initiatives, and manage quality risks.
About You
Required:
- Bachelor's or Master's degree in Biotechnology, Microbiology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
- 7+ years of experience in quality assurance within biotech, pharmaceutical, or medical device manufacturing.
- 3+ years in a managerial or leadership role overseeing QA teams.
- Strong knowledge of US FDA, ISO 13485, and other regulatory standards.
Preferred:
- Experience with QA audits, inspections, CAPA investigations, and risk management.
- Proficiency in QMS software and documentation control systems.
- Strong analytical and problem-solving skills, with a data-driven approach to decision-making.
- Excellent leadership, communication, and cross-functional collaboration skills.
Benefits
- Medical Insurance Plan
- Retirement Plan
- Paid Time Off
- Training & Development
CorDx
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
Alpharetta, GA