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 maintainQuality Management Systems (QMS)in accordance with, US FDA, ISO 13485,and applicableregulations.
- Leadinternal and external audits, regulatory inspections, and corrective action plans (CAPAs).
- Overseebatch record reviews, deviations, non-conformance reports (NCRs), and change controlsto maintain product quality and integrity.
Process & Product Quality Assurance
- Develop and enforceStandard Operating Procedures (SOPs)and best practices to ensure consistent quality across manufacturing operations.
- Collaborate withR&D, production, and regulatory affairs teamsto ensure new products and processes meet quality standards.
- Monitor and analyzequality metrics (KPIs)to drive continuous improvement initiatives.
- Ensure adherence toGood Documentation Practices (GDP)and data integrity policies.
Leadership & Team Development
- Lead, mentor, and develop theQA team, fostering a culture of quality, compliance, and continuous improvement.
- Train manufacturing and quality teams onquality systems, and root cause analysis (RCA)methodologies.
- Serve as the primary point of contact for quality-related issues and escalations.
Risk Management & Continuous Improvement
- Identifyquality risks and implement proactive mitigation strategies.
- Leadinvestigations and root cause analysesfor product defects, deviations, and non-conformances.
- DriveLEAN, Six Sigma, or other process improvement initiativesto enhance efficiency and reduce waste.
- Stay updated on industry trends, new regulations, and technological advancements inmedical device IVD quality assurance.
Requirements
- Bachelor’s or Master’s degree inBiotechnology, Microbiology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
- 7+ years of experiencein quality assurance withinbiotech, pharmaceutical, or medical device manufacturing.
- 3+ years in a managerial or leadership roleoverseeing QA teams.
- Skills & Competencies
- Strong knowledge of USFDA, ISO 13485, and other regulatory standards.
- Experience withQA audits, inspections, CAPA investigations, and risk management.
- Proficiency inQMS 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.
