Quality & Compliance Leader, Medical Devices

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

Job summary

Abbott Laboratories in Atlanta, GA, seeks a Quality Manager for the Heart Failure organization to maintain regulatory compliance and a robust Quality Management System. This role partners with cross-functional teams to prepare for internal and external audits and ensure sustained audit readiness.

You will lead CAPA with strategic direction, manage external requirements, oversee trend analysis, and report to executive management on quality metrics.

Qualifications

• Bachelor’s degree in related field.
• 8+ years in Quality Systems, QA and/or Regulatory Compliance.
• 5+ years in management.
• Knowledge of CFR 803, 806, 820; ISO 13485 & 14971; MDR, MDSAP, NMPA, MDD.

Responsibilities

• Lead site-wide quality systems and regulatory compliance programs.
• Oversee CAPA processes and corrective actions.
• Coordinate external audits and FDA inspections.
• Deliver audit readiness and risk-based improvement initiatives.
• Manage and mentor a diverse quality team.
• Ensure compliance with FDA regulations and ISO standards.

Skills

Quality Systems

Quality Assurance

Regulatory Compliance

Management

Education

Bachelor's degree in related field

Job description

Abbott Laboratories in Atlanta, GA, seeks a Quality Manager for the Heart Failure organization to maintain regulatory compliance and a robust Quality Management System. This role partners with cross-functional teams to prepare for internal and external audits and ensure sustained audit readiness.

You will lead CAPA with strategic direction, manage external requirements, oversee trend analysis, and report to executive management on quality metrics.