Manager, Quality Manager - CAPA

Abbott • Chicago, IL

53d • $129,300 - $258,700 • Onsite

About The Position

The Quality Manager, CAPA provides corporate-level leadership and guidance for Quality Systems matters related to nonconformance, investigation, and Corrective And Preventive Action (CAPA) processes, as well as other related Abbott Quality System elements. This includes providing support, quality and technical expertise, and consulting activities globally to businesses and divisions. The incumbent must possess a working knowledge of global regulations and industry standards pertinent to nonconformance, investigation, and CAPA processes. A strong understanding of the relationship between these processes and other Quality System elements, such as management responsibility, risk management, complaint management, design controls, and validation, is also required. This role is based out of Abbott Park, IL.

Requirements

• 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 (not necessarily the sum of the above) Total combined minimum years of industry experience required.

Responsibilities

• Use established management skills to lead global committees and teams to achieve quality systems objectives, inclusive of training, evaluation of effectiveness of business application of the nonconformance/CAPA processes and implementation of necessary requirements into the corporate wide quality management system, regulatory compliance, and business objectives.
• Act as the corporate liaison to Abbott Businesses/Divisions and provide support as an expert in the subject matter of nonconformance, investigation and CA/PA elements.
• Remain current on regulatory requirements, best practices, and regulatory agency expectations to drive updates in corporate policies and procedures as appropriate.
• Participate in industry groups related to the subject matter areas of responsibility.
• Improve the effectiveness of Abbott’s Quality Systems through monitoring, trending and analyzing quality data and industry intelligence information.
• Act as a change agent for incorporating best practice methods through business support activities such as remediation, training, coaching, continuous improvement initiatives, etc.
• Manage multiple global projects, particularly in nonconformance, investigation, corrective and preventive action including leadership of the Nonconformance and CAPA community of practice (CoP).
• Active leadership and participation and analysis of nonconformance and CAPA quality data and assessments.
• Manage confidential information across the project lifecycle.
• Interact with executive management with accountability for assigned projects.

Benefits

• Free medical coverage for employees via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement
• the Freedom 2 Save student debt program
• FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager