Cordx
Quality Assurance Manager
Alpharetta, Georgia, United States
Sponsorship not specifiedDetected 547 days ago
Data ScienceComplianceProcess ImprovementFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationProblem SolvingRegulatory Affairs
> stay_score
odds of building a lasting career here
16Unrated
Cap-exempt (no lottery)0
Sponsors this role0
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
No strong sponsorship signal in the public record yet. In the full product we resolve the exact legal entity and show its filing history with a confidence score — treat as unverified until then.
Lottery odds assume a STEM candidate.
Personalize to your clock →> community_outcomes
No reports yet — be the first to help the next applicant.
About the role
- 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.
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.
- Leadership & Team Development Lead, mentor, and develop the QA team, fostering a culture of quality, compliance, and continuous improvement.
- 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.
Requirements
- Bachelor's or Master's degree in Biotechnology, Microbiology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
- Experience with QA audits, inspections, CAPA investigations, and risk management.
- Proficiency in QMS software and documentation control systems.
- 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.
Benefits
- Who is CorDx？ CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health.
- 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.
- Stay updated on industry trends, new regulations, and technological advancements in medical device IVD quality assurance.
- 7+ years of experience in quality assurance within biotech, pharmaceutical, or medical device manufacturing.
- 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.
Equal opportunity
- We approach diversity and inclusion seriously and thoughtfully.
This listing is sourced directly from Cordx's careers page and normalized into a canonical job model.