Lead SaMD Quality Engineer - Digital Health & Regulatory

Allergan; North Chicago (IL); On-site; USD 120,000 - 180,000; Full time

Job summary

AbbVie seeks a Lead Digital Health Quality Engineer to drive design controls, DHF management, software validation, and risk management across the software lifecycle. You will author and review QMS documents, support regulatory submissions, and lead continuous improvement in SaMD quality.

Strong cross-functional collaboration and cybersecurity awareness are required. Role requires coordinating audits, CAPA activities, and ensuring compliance with IEC 62304, ISO 14971, and applicable regulations.

Qualifications

• Bachelor’s Degree with 6 years of experience, or Master’s Degree with 5 years, or PhD with 0 years.
• Experience in quality systems, with strong analytical and communications skills.
• Knowledge of IEC 62304, ISO 14971, 21 CFR 820.30 and EU MDR.
• Experience with creation and maintenance of QMS documents for medical devices.

Responsibilities

• Lead design controls and risk management activities per quality system.
• Author, review, and approve QMS and project documentation for SaMD.
• Support regulatory submissions and CAPA activities for SaMD and digital health.
• Coordinate audits and continuous improvement initiatives across cross-functional teams.
• Communicate project and quality status with timely reports to management.
• Exercise latitude in determining objectives and approach.

Skills

Quality systems

Regulatory compliance

Software lifecycle

Cross-functional collaboration

Education

Bachelor’s Degree

Master’s Degree

PhD

Job description

AbbVie seeks a Lead Digital Health Quality Engineer to drive design controls, DHF management, software validation, and risk management across the software lifecycle. You will author and review QMS documents, support regulatory submissions, and lead continuous improvement in SaMD quality.

Strong cross-functional collaboration and cybersecurity awareness are required. Role requires coordinating audits, CAPA activities, and ensuring compliance with IEC 62304, ISO 14971, and applicable regulations.