Senior Quality Software Lead – Digital Health & ISO

abbott; Lake Forest (IL); On-site; USD 99,000 - 199,000; Full time

Benefits offered by this job

Free medical coverage

Strong retirement plan

Tuition reimbursement

Education benefits

Job summary

Abbott is seeking a Principal Professional Quality-Software in Lake Forest, IL, within the Core Lab. The role oversees the Quality Assurance program for Core Dx Digital Health Solution products, ensuring design control, risk management, and post-market surveillance across global teams.

You will lead design reviews, audits, and CAPA activities, working with engineering, product management, IT, and suppliers to embed quality and security throughout the development lifecycle.

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 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.

Responsibilities

• 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 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 continuously improve certified quality management system (ISO 9001, ISO 27001), ensuring alignment to divisional and external requirements.
• Provide quality oversight of suppliers, contractors, and service providers to ensure compliance with quality and information security requirements.
• Assist with external and internal audits, certification assessments, customer audits, and regulatory inspections.
• Collaborate with global quality teams in United States, Portugal, and Italy to drive harmonization of processes.
• May serve as Management Representative for the Quality System and interface with regulatory bodies.

Skills

Quality Assurance

Risk Management

Regulatory Compliance

Software QA

Agile / Scrum

Documentation

Education

Associate’s degree in engineering, QA, or related

Bachelor’s degree in Software/Quality Engineering or related

Job description

Abbott is seeking a Principal Professional Quality-Software in Lake Forest, IL, within the Core Lab. The role oversees the Quality Assurance program for Core Dx Digital Health Solution products, ensuring design control, risk management, and post-market surveillance across global teams.

You will lead design reviews, audits, and CAPA activities, working with engineering, product management, IT, and suppliers to embed quality and security throughout the development lifecycle.