Global CAPA & Quality Systems Leader

Abbott (abbottcareers2 board); Illinois; On-site; USD 120,000 - 180,000; Full time

Job summary

Abbott Park, IL is seeking a Quality Manager, CAPA to lead corporate-level quality systems efforts across nonconformance, investigations and CAPA processes. You will provide global guidance, training, and strategic direction to ensure regulatory compliance and continuous quality improvement.

Ideal candidates have extensive experience in CAPA, root cause analysis, and project management within regulated medical device or pharmaceutical environments.

Qualifications

• Bachelor's Degree required ; Life or Engineering Sciences discipline, preferred.
• Overall 10+ years of experience with 6 years in nonconformance and CAPA processes, root cause analysis tools, quality system continuous improvement experience in a regulated industry required.
• 4 years in Quality Assurance and/or Compliance, managerial, supervisory or SME role; 10+ years in Medical Device, Pharmaceutical and/or Nutritional industry professional-level position.
• 3 years of project management experience (certification is preferred but not required).
• 10-12 years Total combined minimum years of industry experience required.

Responsibilities

• Lead global committees and teams to achieve quality systems objectives, including training and evaluation of effectiveness of CAPA processes and implementation of requirements into the quality management system.
• Act as corporate liaison to Abbott Businesses/Divisions and provide expert support in nonconformance, investigation and CAPA elements.
• Remain current on regulatory requirements and drive updates to corporate policies and procedures.
• Participate in industry groups related to quality responsibility areas.
• Improve Abbott's Quality Systems through monitoring, trending and analyzing quality data and industry intelligence.
• Drive continuous improvement initiatives including remediation, training, coaching and process optimization.

Skills

Quality management

CAPA process

Root cause analysis

Regulatory compliance

Project management

Education

Bachelor's degree in Life or Engineering Sciences

Job description

Abbott Park, IL is seeking a Quality Manager, CAPA to lead corporate-level quality systems efforts across nonconformance, investigations and CAPA processes. You will provide global guidance, training, and strategic direction to ensure regulatory compliance and continuous quality improvement.

Ideal candidates have extensive experience in CAPA, root cause analysis, and project management within regulated medical device or pharmaceutical environments.