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.

• 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.

• 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.

• 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.

• 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.

• 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.? </li></ul>