CorDx · 4 months ago
Quality Assurance Manager
Chamblee, GA
Full-time
Onsite
Senior Level
7+ years expCorDx is a multi-national biotech organization focused on innovation in global health, delivering rapid testing and point-of-care medical device solutions. They are seeking an experienced Quality Assurance Manager to lead their quality assurance team in the development, manufacturing, and distribution of Class II IVD devices, ensuring compliance with regulatory standards and fostering a culture of quality within the organization.
Health CareHealth DiagnosticsMedicalMedical Device
Responsibilities
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
Qualification
Required
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
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
Company
CorDx
CorDx provides medical device solutions to the healthcare industry.
1001-5000 employees
H1B Sponsorship
CorDx has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (2)
2023 (2)
Funding
Current Stage
Late StageRecent News
2025-03-26
Company data provided by crunchbase