Lead SaMD Quality Engineer, Digital Health

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

Benefits offered by this job

Medical/dental/vision insurance

401(k) plan

Short-term incentive programs

Paid time off

Job summary

AbbVie is seeking a Lead Digital Health Quality Engineer to drive design controls, risk management, software validation, and regulatory submissions across SaMD and Digital Health products. You will author and review QMS documentation, lead quality improvements, and collaborate with cross-functional teams to ensure compliance with IEC 62304, ISO 14971, 21 CFR 820.30 and EU MDR.

You will guide lifecycle activities, support audits, and contribute to cybersecurity quality programs while coordinating

Qualifications

• Experience in a quality systems environment and cross-functional teamwork.
• Ability to author and review QMS documentation for SaMD and Digital Health.
• Knowledge of SDLC, design controls, risk management, and regulatory submissions.

Responsibilities

• Ensure compliance with corporate/divisional policies and global regulations for Digital Health and SaMD.
• Lead design controls and risk management activities, including cybersecurity risk management.
• Contribute to software validation and lifecycle activities per CSA and GAMP5.
• Write/review processes and documents for SaMD and Digital Health product development.
• Support regulatory submissions and CAPA activities related to quality issues.
• Lead continuous improvement initiatives in Design History File and Risk Management.

Skills

Quality engineering

Regulatory compliance

Design controls

Risk management

Cybersecurity risk management

GAMP5

IEC 62304

ISO 14971

21 CFR 820.30

EU MDR

Education

Bachelor’s degree

Master’s degree

Job description

AbbVie is seeking a Lead Digital Health Quality Engineer to drive design controls, risk management, software validation, and regulatory submissions across SaMD and Digital Health products. You will author and review QMS documentation, lead quality improvements, and collaborate with cross-functional teams to ensure compliance with IEC 62304, ISO 14971, 21 CFR 820.30 and EU MDR.

You will guide lifecycle activities, support audits, and contribute to cybersecurity quality programs while coordinating