Quality & Compliance Leader – Medical Device Audits

Regulatory Jobs; Atlanta (GA); On-site; USD 113,000 - 227,000; Full time

Benefits offered by this job

Health coverage

Employer retirement contribution

Tuition reimbursement

FreeU education benefit

Job summary

Abbott is seeking a Quality Manager for the Heart Failure organization in Atlanta to maintain Quality Management System compliance with internal policies, standards, and external regulatory requirements.

You will lead audits, CAPA programs, and cross-functional initiatives, ensuring regulatory readiness and continual quality improvements across the site. Strong leadership, communication, and regulatory expertise are essential for success in this role.

Qualifications

• Bachelor’s degree in related field is required.
• Eight (8) years of Quality Systems, Quality Assurance and/or Regulatory Compliance/Affairs experience in medical device manufacturing or similar regulated environment.
• Five (5) years in a management capacity.

Responsibilities

• Define and develop strategy for external and internal audits to ensure audit readiness.
• Drive cross-functional audit support and audit readiness initiatives.
• Ensure quality system requirements understand by cross-functional partners and impact on product quality and regulatory compliance.
• Lead site-wide CAPA program and drive robust investigations and global resolutions.
• Oversee External Requirements change impact assessment metrics and timely regulatory changes.

Skills

Leadership

Communication

Analytical skills

Education

Bachelor’s degree in related field

Job description

Abbott is seeking a Quality Manager for the Heart Failure organization in Atlanta to maintain Quality Management System compliance with internal policies, standards, and external regulatory requirements.

You will lead audits, CAPA programs, and cross-functional initiatives, ensuring regulatory readiness and continual quality improvements across the site. Strong leadership, communication, and regulatory expertise are essential for success in this role.