Manager, Quality Manager - CAPA

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

JOB DESCRIPTION:

Quality Manager, CAPA

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to:

• 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 and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

The function of the Quality Manager, CAPA is to provide corporate-level leadership and guidance for Quality Systems matters related to nonconformance, investigation and C orrective And P reventive A ction (CAPA) processes and other related Abbott Quality System elements. This includes Business/Division support, quality and technical expertise and consulting activities globally. The incumbent must have a working knowledge of global regulations and industry standards related to nonconformance, investigation, and Corrective And Preventive Action (CAPA) processes. The incumbent should also have working knowledge and understand the relationship to other related Quality System elements, e.g., management responsibility, risk management, complaint management, design controls, validation, etc.

This role will be based out of Abbott Park, I l

What You'll Work On

• 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 n onconformance, 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.

The scope of this position is Abbott-wide, covering all Abbott Businesses / Divisions.

This position manages multiple global projects, particularly in n on conformance , investigation, c orrective and p reventive 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.

Given the nature of the projects as they relate to regulatory and quality compliance, the financial consequences for adverse regulatory findings or delayed product approval initiatives can be significant

This position manages confidential information across the project lifecycle.

This position requires significant interaction with executive management with accountability for assigned projects.

Required Qualifications

• Bachelor's Degree required ; Life or Engineering Sciences discipline, preferred.
• Overall 10+ years of experience with 6 years in n onconformance and CAPA process es, 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 yea rs (not necessarily the sum of the above) Total combined minimum years of industry experience required .

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://abbottbenefits.com/

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