Global CAPA Quality Leader | Regulatory & CI Expert

Regulatory Jobs; Illinois; Presencial; USD 129.000 - 259.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Free medical coverage (HIP PPO)

Strong retirement plan with employer 2

Tuition reimbursement

Descripción de la vacante

Abbott Park, IL is seeking a Quality Manager, CAPA to provide corporate-level leadership for CAPA and nonconformance processes across Abbott’s Quality System. You will guide investigations, root-cause analyses, and cross‑functional remediation, while ensuring compliance with global regulations.

The role requires extensive experience in quality systems, CAPA, and project management within regulated industries.

Formación

• Bachelor’s Degree in Life or Engineering Sciences required.
• Overall 10+ years of experience with 6 years in nonconformance and CAPA processes, root cause analysis tools, quality system continuous improvement in a regulated industry.
• 4 years in Quality Assurance and/or Compliance, managerial, supervisory or SME role; 10+ years in Medical Device, Pharmaceutical and/or Nutritional industry.

Responsabilidades

• Lead global committees and teams to achieve quality systems objectives and drive CAPA processes.
• Act as corporate liaison to Abbott Businesses/Divisions on nonconformance and CAPA elements.
• Stay current on regulatory requirements and industry best practices to update policies and procedures.
• Participate in industry groups related to responsibility areas.
• Monitor and analyze quality data to improve Abbott’s Quality Systems.
• Lead change initiatives and training across functions.
• Oversee CAPA across Abbott-wide scope and governance.

Conocimientos

CAPA

Quality systems

Investigation

Nonconformance

Root cause analysis

Project management

Educación

Bachelor’s Degree in Life or Engineering Sciences

Descripción del empleo

Abbott Park, IL is seeking a Quality Manager, CAPA to provide corporate-level leadership for CAPA and nonconformance processes across Abbott’s Quality System. You will guide investigations, root-cause analyses, and cross‑functional remediation, while ensuring compliance with global regulations.

The role requires extensive experience in quality systems, CAPA, and project management within regulated industries.