Senior QA Manager

Senior Qa 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.

Location : Atlanta, GA

Position Type : 5 Days Onsite Exempt Position

Responsibilities :

• Manage and supervise the QA team's daily activities, ensuring timely and effective execution of quality processes.
• Support the implementation and maintenance of the company's QMS, ensuring ongoing compliance with FDA 21 CFR Part 820, ISO 13485, and other relevant standards.
• Collaborate with R&D, Manufacturing, Regulatory Affairs, and Operations teams to integrate quality requirements into product development, manufacturing, and support processes.
• Lead and support internal and external audits, supplier audits, and management reviews, including preparation of required documentation and follow-up actions.
• Oversee the management of non-conformances (NCRs), CAPAs, complaints, and deviations, ensuring timely investigations, root cause analysis, and effective corrective and preventive actions.
• Assist in the preparation for regulatory inspections and third-party audits, serving as a key member of the audit response team.
• Monitor and interpret relevant regulatory changes and industry trends, advising management on necessary updates to quality systems and processes.
• Develop and track quality metrics (KPIs) to monitor the effectiveness of the QA program and identify opportunities for improvement.
• Provide training and mentorship to QA staff, fostering a culture of continuous improvement and compliance.
• Support risk management activities, including risk assessments and mitigation planning.