Senior Quality Software Lead, Digital Health Solutions

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 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.