Quality Assurance Manager

Who is 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.

Position : QA Manager

Location : Alpharetta / Chamblee

Position Type : 5 days Onsite Exempt Position

Job Summary : We are seeking an experienced Quality Assurance Manager to lead our quality assurance team in the development, manufacturing, and distribution of Class II IVD devices. The ideal candidate will have at least 7 years of experience in the IVD industry, with a strong background in quality management systems, regulatory compliance, and team leadership.

Key Responsibilities :

Quality Systems & Compliance

• 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, non-conformance reports (NCRs), and change controls  to maintain product quality and integrity.

Process & Product Quality Assurance

Leadership & Team Development

Risk Management & Continuous Improvement

Requirements

Benefits

We are an equal-opportunity employer and celebrate diversity, recognizing that diversity of thought and background builds stronger teams. We approach diversity and inclusion seriously and thoughtfully. We do not discriminate on the basis of race, religion, color, ancestry, national origin, caste, sex, sexual orientation, gender, gender identity or expression, age, disability, medical condition, pregnancy, genetic makeup, marital status, or military service.