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Job DescriptionJob Description
Who is CorDx？
CorDx a multi- 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, , 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.
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.
Ensure adherence to
Good Documentation Practices (GDP)
and data integrity policies.
Leadership & Team Development
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.
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.
Stay updated on industry trends, new regulations, and technological advancements in
medical device IVD quality assurance .
Requirements
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.
Benefits
Medical Insurance Plan
Retirement Plan
Paid Time Off
Training & Development
We are an equal-opportunity employer and celebrate , recognizing that of thought and background builds stronger teams. We approach and seriously and thoughtfully. We do not discriminate on the basis of , , , ancestry, , caste, , , , or expression, , , medical condition, , genetic makeup, marital status, or military service.
Who is CorDx？
CorDx a multi- 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, , 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.
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.
Ensure adherence to
Good Documentation Practices (GDP)
and data integrity policies.
Leadership & Team Development
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.
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.
Stay updated on industry trends, new regulations, and technological advancements in
medical device IVD quality assurance .
Requirements
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.
Benefits
Medical Insurance Plan
Retirement Plan
Paid Time Off
Training & Development
We are an equal-opportunity employer and celebrate , recognizing that of thought and background builds stronger teams. We approach and seriously and thoughtfully. We do not discriminate on the basis of , , , ancestry, , caste, , , , or expression, , , medical condition, , genetic makeup, marital status, or military service.