Principle Professional Quality - Software

Abbott; Chicago (IL); On-site; USD 99,000 - 199,000; Full time

Benefits offered by this job

Health coverage

Tuition reimbursement

Retirement plan

Education benefits

Job summary

Abbott in Lake Forest, IL, seeks a Principal Professional Quality-Software to lead the QA program for Core Dx Digital Health Solution products. The role ensures quality and information security across design, development, and post-market activities.

You will guide risk management, CAPA, supplier quality, and audits, collaborating with engineering, product management, and IT teams to drive continuous improvement in a fast-paced, global environment.

Qualifications

• Associate’s degree in engineering, quality assurance, or a related technical field.
• Minimum 3+ years of experience in quality assurance or quality control, preferably in product development, regulated environments, non-medical products, or digital health.
• Experience with ISO 9001 and ISO 27001 quality systems preferred.

Responsibilities

• Serve as quality SME for digital health solutions, guiding quality, compliance, risk management, and software development best practices.
• Lead quality assurance efforts across the product lifecycle, including design reviews, risk assessments, verification and validation, change control, and product release.
• Collaborate with engineering, product management, and IT to ensure quality and security requirements are integrated into design, development, and maintenance processes.
• Support post-market surveillance and customer feedback analysis to drive product improvements and compliance.
• Oversee key quality system processes, including document control, nonconformance and CAPA management, and internal audits related to product quality and information security.
• Maintain and improve ISO 9001, ISO 27001 certified QMS, aligning with internal, corporate, and external requirements.
• Provide quality oversight of suppliers, contractors, and service providers to ensure compliance with quality and information security requirements.
• Support external/internal audits, certification assessments, customer audits, and regulatory inspections, ensuring readiness and effective observations resolution.
• Collaborate with global quality teams and technical teams in the US, Portugal, and Italy to harmonize quality processes.

Skills

Quality assurance

Agile development

Design control

Risk management

Post-market surveillance

Regulatory alignment

Education

Associate’s degree in engineering or related field

Bachelor’s degree in Software/Quality Engineering or related discipline

Tools

ISO 9001

ISO 27001

Cybersecurity basics

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

Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a 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.
• A company recognized as a great place to work in dozens of countries worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Lake Forest, IL location in the Core Lab, Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.

Position Overview

The Principal Professional Quality-Software is responsible for the implementation and management of the Quality Assurance program for the Core Dx Digital Health Solution products. The role includes oversight of design and development quality processes, post-market support, and continuous improvement initiatives. The Principal Professional Quality position ensures that product quality and information security standards meet or exceed internal and external requirements and maintains the standard of excellence established by the Core Dx division.

What You’ll Work On

• Serve as a quality subject matter expert for digital health solutions, providing guidance on quality, compliance, risk management, and software development best practices.
• Lead quality assurance efforts throughout the product lifecycle, including design reviews, risk assessments, verification and validation activities, change control, and product release.
• Collaborate with engineering, product management, and IT teams to ensure quality and security requirements are effectively integrated into design, development, and maintenance processes.
• Support post-market surveillance and customer feedback analysis to drive product improvements and ensure continued compliance.
• Oversee key quality system processes, including document control, nonconformance and CAPA management, and internal audits related to both product quality and information security.
• Maintain and continuously improve certified quality management system (ISO 9001, ISO 27001, etc.), ensuring alignment to divisional, corporate, and external requirements.
• Provide quality oversight of suppliers, contractors, and service providers to ensure compliance with established quality and information security requirements.
• Support and facilitate external and internal audits, certification assessments, customer audits, and regulatory inspections, ensuring organizational readiness and effective resolution of observations.
• Collaborate with global quality teams and technical teams in United States, Portugal, and Italy to drive harmonization, consistency, and continuous improvement across quality processes.
• May serve as the Management Representative for the Quality System; acts as a point of contact providing quality guidance and expertise for digital products to represent the organization as the main interface with necessary regulatory bodies and external auditors.

Required Qualifications

• Associate’s degree in engineering, quality assurance, or a related technical field.
• Minimum 3+ years of experience in quality assurance or quality control, preferably in product development, regulated environments, non-medical products, or digital health.
• Experience with ISO 9001 and ISO 27001 quality systems preferred.
• Familiarity with agile development, design control, risk management, and post-market surveillance processes.

Preferred Qualifications

• Bachelor’s degree in Software Engineering, Computer Science, Quality Engineering, Biomedical Engineering, Information Systems, or a related technical discipline.
• 6+ years of progressive Quality Assurance experience supporting software, digital health, diagnostics, medical devices, or other regulated product environments.
• Demonstrated ability to lead design reviews, risk assessments, root cause investigations, CAPA activities, and supplier quality management.
• Knowledge of software development methodologies, including Agile and Scrum, with familiarity in cybersecurity and information security principles, risk management frameworks, secure software development practices, and information security controls.
• Proven ability to independently manage multiple priorities, lead complex quality initiatives, and deliver results in a fast-paced, global environment with cross-functional teams, including engineering, product management, marketing, regulatory affairs, IT, cybersecurity, and suppliers.
• Strong communication, organizational, and problem-solving skills, with the ability to influence stakeholders and drive continuous improvement.

Employment Details

• The base pay for this position is $99,300.00 – $198,700.00
• JOB FAMILY: Operations Quality
• DIVISION: CRLB Core Lab
• LOCATION: United States > Lake Forest : CP01
• ADDITIONAL LOCATIONS:
• WORK SHIFT: Standard
• TRAVEL: Yes, 10 % of the Time
• MEDICAL SURVEILLANCE: Not Applicable
• 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, committed to employee diversity.

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 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.

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