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
- Develop and enforce Standard Operating Procedures (SOPs) and best practices to ensure consistent quality across manufacturing operations.
- Collaborate with R&D, production, and regulatory affairs teams to ensure new products and processes meet quality standards.
- Monitor and analyze quality metrics (KPIs) to drive continuous improvement initiatives.
- Ensure adherence to Good Documentation Practices (GDP) and data integrity policies.
Leadership & Team Development
- Lead, mentor, and develop the QA team, fostering a culture of quality, compliance, and continuous improvement.
- Train manufacturing and quality teams on quality systems, and root cause analysis (RCA) methodologies.
- Serve as the primary point of contact for quality-related issues and escalations.
Risk Management & Continuous Improvement
- Identify quality risks and implement proactive mitigation strategies.
- Lead investigations and root cause analyses for product defects, deviations, and non-conformances.
- Drive LEAN, Six Sigma, or other process improvement initiatives to enhance efficiency and reduce waste.
- Stay updated on industry trends, new regulations, and technological advancements in medical device IVD quality assurance.
Requirements
- 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.
- Skills & Competencies
- Strong knowledge of US FDA, ISO 13485, and other regulatory standards.
- 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
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.