Senior Quality Software Lead, Digital Health

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 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