Manager, Quality Manager - CAPA

About this role

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. 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:  

• Career development with an international company where you can grow the career you dream of.  

• 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 .   

Apply Now  

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

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.  

Connect with us at   abbott.com , on LinkedIn at   https://www.linkedin.com/company/abbott-/ , and on Facebook at   https://www.facebook.com/AbbottCareers .  

The base pay for this position is $129,300.00 – $258,700.00 In specific locations, the pay range may vary from the range posted.       JOB FAMILY: Operations Quality DIVISION: AQR Abbott Quality and Regulatory LOCATION: United States > Abbott Park : AP52 ADDITIONAL LOCATIONS:

WORK SHIFT: Standard TRAVEL: Yes, 50 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIE

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