Senior Quality Software Lead, Digital Health Solutions

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

Benefits offered by this job

Free medical coverage (HIP PPO)

Excellent retirement savings plan

Tuition reimbursement

FreeU education benefit

Diversity-friendly employer

Job summary

Abbott Laboratories in Lake Forest, IL, seeks a Principal Professional Quality-Software to lead the quality assurance program for Core Dx Digital Health Solution products. You will oversee design and development quality processes, post-market support, and continuous improvement initiatives.

The role requires 3+ years in QA, familiarity with ISO 9001 and ISO 27001, and strong collaboration with engineering, product management, and IT teams across functions.

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.

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 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.

Skills

Quality assurance

ISO 9001

ISO 27001

Agile development

Risk management

Software quality

Regulatory compliance

Education

Associate’s degree in engineering, quality assurance, or related field

Bachelor’s degree in Software Engineering/Computer Science/Quality Engineering

Job description

Abbott Laboratories in Lake Forest, IL, seeks a Principal Professional Quality-Software to lead the quality assurance program for Core Dx Digital Health Solution products. You will oversee design and development quality processes, post-market support, and continuous improvement initiatives.

The role requires 3+ years in QA, familiarity with ISO 9001 and ISO 27001, and strong collaboration with engineering, product management, and IT teams across functions.