Quality Manager

Quality Manager

CorDx is 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.

Job Type : Full time

Location : Onsite - Atlanta Office

We are seeking an experienced Quality Manager to join our team in the IVD (In Vitro Diagnostic) industry. The ideal candidate will have a minimum of 10 years of relevant experience in the medical device manufacturing sector, with a strong background in quality management systems, regulatory compliance, and ISO standards. The Quality Manager will play a critical role in implementing, managing, and improving our company's quality management system, with a focus on IVD products and equipment.

Key Responsibilities :

• Implement, manage, and improve the company's quality management system, with a primary focus on IVD products and equipment.
• Conduct internal audits, compile audit reports, perform problem analysis, propose improvement initiatives, and monitor the implementation of corrective and preventive actions (CAPA).
• Lead and participate in internal audits and management reviews of the company's quality system as a key member of the quality department.
• Manage the documentation of the company's quality management system, ensuring compliance with relevant standards and regulations.
• Oversee the quality management system for IVD equipment, ensuring compliance with applicable regulations and standards.
• Perform statistical analysis of IVD equipment quality data, prepare reports, and develop corrective and preventive measures as needed.
• Update company documents in accordance with new or revised quality standards, laws, and regulations.
• Establish collaborative relationships with key opinion leaders and certification bodies to ensure alignment with industry best practices and regulatory requirements.