Manager, Quality Manager - CAPA

Thornton Tomasetti; North Chicago (IL); On-site; USD 129,000 - 259,000; Full time

Benefits offered by this job

Free medical coverage for employees

Retirement savings plan with high‑emlo

Tuition reimbursement

FreeU education benefit

Job summary

Abbott Park, IL-based Quality Manager, CAPA, leads global quality systems initiatives and CAPA programs. This role provides corporate-level guidance on nonconformance and investigations, driving regulatory alignment and best practices across Abbott’s businesses and divisions.

Successful candidates will influence quality culture, mentor teams, and manage cross-functional projects with significant regulatory and financial impact.

Qualifications

• Bachelor’s Degree in Life or Engineering Sciences.
• 10+ years of experience with 6 years in nonconformance and CAPA.
• 4 years in Quality Assurance and/or Compliance, managerial or SME role.
• 3 years of project management experience.
• Total 10–12 years of industry experience.

Responsibilities

• Lead global committees and teams to achieve quality systems objectives.
• Serve as corporate liaison on nonconformance, investigation and CAPA elements.
• Stay current on regulatory requirements, best practices and agency expectations.
• Improve Abbott’s Quality Systems through monitoring, trending and data analysis.
• Manage multiple global projects including leadership of the CAPA CoP.

Skills

CAPA

Nonconformance

Root cause analysis

Quality systems

Regulatory compliance

Project management

Quality Assurance

Education

Bachelor’s degree in Life or Engineering Sciences

Job description

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 122,000 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 Corrective And Preventive Action (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, Il

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

Compensation

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 Details

• 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 ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott is an Equal Opportunity Employer, committed to employee diversity.

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.