Manager, Quality Manager - CAPA

Regulatory Jobs; Illinois; Presencial; USD 129.000 - 259.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Free medical coverage (HIP PPO)

Strong retirement plan with employer 2

Tuition reimbursement

Descripción de la vacante

Abbott Park, IL is seeking a Quality Manager, CAPA to provide corporate-level leadership for CAPA and nonconformance processes across Abbott’s Quality System. You will guide investigations, root-cause analyses, and cross‑functional remediation, while ensuring compliance with global regulations.

The role requires extensive experience in quality systems, CAPA, and project management within regulated industries.

Formación

• Bachelor’s Degree in Life or Engineering Sciences required.
• Overall 10+ years of experience with 6 years in nonconformance and CAPA processes, root cause analysis tools, quality system continuous improvement in a regulated industry.
• 4 years in Quality Assurance and/or Compliance, managerial, supervisory or SME role; 10+ years in Medical Device, Pharmaceutical and/or Nutritional industry.

Responsabilidades

• Lead global committees and teams to achieve quality systems objectives and drive CAPA processes.
• Act as corporate liaison to Abbott Businesses/Divisions on nonconformance and CAPA elements.
• Stay current on regulatory requirements and industry best practices to update policies and procedures.
• Participate in industry groups related to responsibility areas.
• Monitor and analyze quality data to improve Abbott’s Quality Systems.
• Lead change initiatives and training across functions.
• Oversee CAPA across Abbott-wide scope and governance.

Conocimientos

CAPA

Quality systems

Investigation

Nonconformance

Root cause analysis

Project management

Educación

Bachelor’s Degree in Life or Engineering Sciences

Descripción del empleo

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’llalso 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, theFreedom 2 Savestudent debtprogramandFreeUeducation benefit - an affordable and convenient path to getting a bachelor’s degree.

• A company recognized asa great placeto 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 tononconformance, investigation andCorrective AndPreventiveAction (CAPA) processes and other related Abbott Quality System elements. This includes Business/Division support, quality and technicalexpertiseandconsulting 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 haveworkingknowledge and understand the relationship to other related Quality System elements, e.g., management responsibility, risk management, complaint management, design controls, validation, etc.

This rolewillbe based out ofAbbott Park, Il

What You'll Work On

• Use established management skills to lead global committees and teams to achieve qualitysystems objectives,inclusive of training, evaluation of effectiveness of business application of the nonconformance/CAPAprocesses andimplementation of necessary requirements into the corporate wide quality management system,regulatory compliance, and businessobjectives.

• Act as the corporate liaison to Abbott Businesses/Divisions and provide support as an expert in the subject matter ofnonconformance, investigation and CA/PA elements.

• Remain current on regulatory requirements, best practices, and regulatory agency expectations to drive updates in corporate policies and procedures asappropriate.

• Participate in industry groups related to the subjectmatterareas of responsibility.

• Improve the effectiveness of Abbott’s Quality Systems through monitoring,trendingandanalyzingquality 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, particularlyinnonconformance, investigation,corrective andpreventive action including leadership of the Nonconformance and CAPA community of practice (CoP).

• Active leadership and participationand analysis of nonconformance and CAPA quality dataand 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 Degreerequired; Life or Engineering Sciences discipline, preferred.

• Overall10+ years of experience with 6 years innonconformance and CAPAprocesses, root cause analysis tools,quality systemcontinuous improvementexperience in a regulated industryrequired.

• 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 ispreferred butnotrequired).

• 10-12 years (not necessarily the sum of the above)Total combined minimum years of industry experiencerequired.

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 atabbott.com, on LinkedIn athttps://www.linkedin.com/company/abbott-/, and on Facebook athttps://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

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.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf