Quality Manager
Job in
Atlanta, Fulton County, Georgia, 30383, USA
Listing for:
CorDx
Full Time, Seasonal/Temporary
position
Listed on 2026-01-03
Job specializations:
-
Quality Assurance - QA/QC
-
Healthcare
Data Scientist, Medical Science
Job Description & How to Apply Below
Overview
Cor Dx is 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, Cor Dx 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.
Cor Dx 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.
Job Type: Full time
Job Title: Quality Manager
Location: Onsite - Atlanta Office
Responsibilities
Implement, manage, and improve the company’s quality management system, with a primary focus on IVD products and equipment.Conduct internal audits, compile audit reports, perform problem analysis, propose improvement initiatives, and monitor the implementation of corrective and preventive actions (CAPA).Lead and participate in internal audits and management reviews of the company's quality system as a key member of the quality department.Manage the documentation of the company’s quality management system, ensuring compliance with relevant standards and regulations.Oversee the quality management system for IVD equipment, ensuring compliance with applicable regulations and standards.Perform statistical analysis of IVD equipment quality data, prepare reports, and develop corrective and preventive measures as needed.Update company documents in accordance with new or revised quality standards, laws, and regulations.Establish collaborative relationships with key opinion leaders and certification bodies to ensure alignment with industry best practices and regulatory requirements.Qualifications
Minimum Bachelor’s degree in Science or related field.ISO 13485:2016 lead auditor certification preferred.Thorough knowledge of US FDA 21 CFR 820 Quality System Regulation and ISO 13485:2016 standards.Strong understanding of quality management principles and practices in the medical device industry.Excellent communication and interpersonal skills.Ability to work collaboratively in a team environment.Demonstrated problem-solving and analytical skills.Attention to detail and strong organizational skills.Minimum 10 Years experience in Medical devices, Quality Management, Regulatory compliance and ISO standardsBenefits
- Health Care Plan (Medical)
- 401K
- 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.
#J-18808-Ljbffr
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
