Quality Manager

CorDx; Georgia; On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health Care Plan (Medical)

401K

Paid Time Off

Training & Development

Job summary

CorDx is seeking an experienced Quality Manager to join our team onsite at the Atlanta office. You will lead the quality management system for IVD products, drive regulatory compliance, and oversee internal audits, CAPA, and management reviews.

The ideal candidate has 10+ years in medical devices, strong knowledge of ISO 13485 and FDA 21 CFR 820, and excellent communication and leadership skills. This role supports our global health initiatives and growth in the IVD sector.

Qualifications

• Bachelor’s degree in Science or related field.
• 10+ years in medical device quality/regulatory.
• Experience with ISO 13485:2016 and FDA 21 CFR 820.
• Lead auditor certification preferred.

Responsibilities

• Develop and manage the quality management system for IVD products and equipment.
• Lead internal audits, CAPA investigations, and management reviews.
• Maintain and improve documentation to ensure regulatory compliance.
• Coordinate regulatory submissions and interface with certification bodies.
• Perform statistical analysis of quality data and implement improvements.
• Update quality policies and procedures to reflect new standards.
• Collaborate with cross-functional teams to ensure product quality.
• Establish relationships with audiences and stakeholders to maintain best practices.

Skills

Quality management

Regulatory compliance

Auditing

CAPA

Education

Bachelor’s degree in Science

ISO 13485:2016 Lead Auditor

Job description

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.

Job Type: Full time

Job Title: Quality Manager

Location: Onsite - Atlanta Office

We are seeking an experienced Quality Manager to join our team in the IVD (In Vitro Diagnostic) industry. The ideal candidate will have a minimum of 10 years of relevant experience in the medical device manufacturing sector, with a strong background in quality management systems, regulatory compliance, and ISO standards. The Quality Manager will play a critical role in implementing, managing, and improving our company’s quality management system, with a focus on IVD products and equipment.

Key Responsibilities:

1. Implement, manage, and improve the company’s quality management system, with a primary focus on IVD products and equipment.
2. Conduct internal audits, compile audit reports, perform problem analysis, propose improvement initiatives, and monitor the implementation of corrective and preventive actions (CAPA).
3. Lead and participate in internal audits and management reviews of the company’s quality system as a key member of the quality department.
4. Manage the documentation of the company’s quality management system, ensuring compliance with relevant standards and regulations.
5. Oversee the quality management system for IVD equipment, ensuring compliance with applicable regulations and standards.
6. Perform statistical analysis of IVD equipment quality data, prepare reports, and develop corrective and preventive measures as needed.
7. Update company documents in accordance with new or revised quality standards, laws, and regulations.
8. Establish collaborative relationships with key opinion leaders and certification bodies to ensure alignment with industry best practices and regulatory requirements.

Requirements

1. Minimum Bachelor’s degree in Science or related field.
2. ISO 13485:2016 lead auditor certification preferred.
3. Thorough knowledge of US FDA 21 CFR 820 Quality System Regulation and ISO 13485:2016 standards.
4. Strong understanding of quality management principles and practices in the medical device industry.
5. Excellent communication and interpersonal skills.
6. Ability to work collaboratively in a team environment.
7. Demonstrated problem-solving and analytical skills.
8. Attention to detail and strong organizational skills.
9. Minimum 10 Years experience in Medical devices, Quality Management , Regulatory compliance and ISO standards

Benefits

• 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.