Quality Assurance Manager
CorDxGeorgia, United States • Alpharetta, Georgia, United States
Posted January 31, 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 is seeking an experienced Quality Assurance Manager to lead their quality assurance team for Class II IVD devices. The role involves developing, implementing, and maintaining QMS, leading audits, and ensuring product quality and regulatory compliance. The company focuses on diagnostic solutions for infectious diseases and is at the cutting edge of AI and data science.
Requirements
- Develop, implement, and maintain Quality Management Systems (QMS) in accordance with US FDA, ISO 13485, and applicable regulations.
- Lead internal and external audits, regulatory inspections, and corrective action plans (CAPAs).
- Oversee batch record reviews, deviations, and non-conformance reports (NCRs).
- Develop and enforce Standard Operating Procedures (SOPs) and best practices.
- Collaborate with R&D, production, and regulatory affairs teams.
- Monitor and analyze quality metrics to drive continuous improvement initiatives.
- Ensure adherence to Good Documentation Practices (GDP) and data integrity policies.
- Lead, mentor, and develop the QA team.
Benefits
- Medical Insurance Plan
- Retirement Plan
- Paid Time Off
- Training & Development