Principle Professional Quality - Software

Abbott (abbottcareers2 board); Lake Forest (IL); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Career development

Health benefits

Retirement savings plan

Tuition reimbursement

Education benefits

Job summary

Abbott Lake Forest, IL, is seeking a Principal Professional Quality-Software to implement and manage the QA program for Core Dx Digital Health Solution products. You will oversee design and development quality processes, post-market support, and ongoing improvements to meet quality and information security standards.

You will lead QA activities across the product lifecycle, collaborate with engineering, product management, and IT, and ensure compliance with regulatory and internal requirements

Qualifications

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

Responsibilities

• Serve as quality subject matter expert for digital health solutions, guiding 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 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 product quality and information security.
• Maintain and improve certified quality management systems (ISO 9001, ISO 27001) alignment with divisional and external requirements.
• Provide quality oversight of suppliers, contractors, and service providers to ensure compliance with quality and information security requirements.
• Support external and internal audits, certification assessments, customer audits, and regulatory inspections, ensuring readiness and effective resolution of observations.
• Collaborate with global quality teams (US, Portugal, Italy) to drive harmonization and continuous improvement across quality processes.

Skills

Quality assurance

Regulated environments

Risk management

Agile development

Post-market surveillance

Education

Associate's degree in engineering/quality assurance

Bachelor's degree in Software Engineering/CS/QA/BIomedical/IS

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.

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, 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 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.

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 Principle 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, roo