Senior IVD Quality Assurance & Compliance Lead

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

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.