Lead Quality Assurance for Digital Health Software

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

Benefits offered by this job

Free medical coverage

Excellent retirement plan

Tuition reimbursement

Job summary

Abbott is seeking a Principal Professional Quality-Software at our Lake Forest, IL site in Core Lab. You will lead the Quality Assurance program for Core Dx Digital Health Solution products, ensuring ISO 9001/27001 alignment and regulatory readiness while collaborating with Global teams.

Responsibilities include guiding quality practices across design, development, and post-market activities, overseeing CAPA, document control, supplier quality, and audits, with emphasis on security and risk

Qualifications

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

Responsibilities

• Serve as quality subject matter expert for digital health solutions and regulatory compliance.
• Lead QA efforts through the product lifecycle: design reviews, risk assessments, verification and validation, change control, and product release.
• Collaborate with engineering, product, and IT to integrate quality and security requirements into design and maintenance processes.
• Support post-market surveillance and customer feedback analyses to drive product improvements and compliance.
• Oversee document control, nonconformance/CAPA management, and internal audits related to product quality and information security.
• Maintain and improve ISO 9001, ISO 27001 certified QMS.
• Provide quality oversight of suppliers and service providers.
• Support audits, certifications, and regulatory inspections; ensure readiness and issue resolution.
• Collaborate with global quality teams for harmonization and continuous improvement across processes.

Skills

Quality Assurance

Regulated Environments

Agile Methodologies

Design Reviews

Risk Management

CAPA Management

Supplier Quality

Education

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

Bachelor’s degree in Software Engineering, Computer Science, Quality Engineering, Biomedical Engineering, Information Systems, or related

Tools

ISO 9001

ISO 27001

Cybersecurity Principles

Secure SDLC

Job description

Abbott is seeking a Principal Professional Quality-Software at our Lake Forest, IL site in Core Lab. You will lead the Quality Assurance program for Core Dx Digital Health Solution products, ensuring ISO 9001/27001 alignment and regulatory readiness while collaborating with Global teams.

Responsibilities include guiding quality practices across design, development, and post-market activities, overseeing CAPA, document control, supplier quality, and audits, with emphasis on security and risk