Lead SaMD Quality Engineer – Digital Health & Compliance

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

Benefits offered by this job

PTO

Medical insurance

401(k)

Incentives

Job summary

AbbVie in the United States invites a Lead Digital Health Quality Engineer to lead design controls, risk management, and software validation for SaMD and Digital Health products, ensuring compliance with IEC 62304, ISO 14971, 21 CFR 820.30, and EU MDR across the software life cycle.

You will author and review QMS documents, support regulatory submissions and audits, lead CAPA activities, and collaborate with cross‑functional teams to drive quality improvements, cybersecurity considerations, and

Qualifications

• Bachelor’s Degree with 6 years of experience; or Master’s Degree with 5 years of experience; or PhD with 0 years of experience.
• Experience coordinating complex activities and resolving problems through technical and interpersonal skills.
• Experience in a quality systems environment; analytical, judgmental, and communication skills; cross-functional teamwork.
• Exhibits latitude in determining objectives and approach.
• Strong understanding of IEC 62304, ISO 14971, 21 CFR 820.30 and EU MDR.
• Experience creating and maintaining QMS documents for medical devices development.

Responsibilities

• Ensure compliance with global regulations governing Digital Health apps and SaMD, including software lifecycle requirements.
• Perform design control and risk management activities per Quality System, partnering with technical teams.
• Experience with CSA and GAMP5 principles for software validation and lifecycle activities.
• Write/review SaMD and Digital Health development documents in compliance with global regulations.
• Support regulatory submission documentation and audits.
• Lead CAPA activities and root-cause analysis for SaMD quality issues.
• Lead continuous improvement initiatives within Design History File and Risk Management.
• Serve as SME on SaMD/Digital Health quality and regulatory requirements across cross-functional teams.
• Communicate project and quality status through timely reports and recommendations.

Skills

Quality systems

Design controls

Risk management

Regulatory knowledge

CSA & GAMP5

Cross-functional collaboration

Education

Bachelor’s Degree

Master’s Degree

PhD

Job description

AbbVie in the United States invites a Lead Digital Health Quality Engineer to lead design controls, risk management, and software validation for SaMD and Digital Health products, ensuring compliance with IEC 62304, ISO 14971, 21 CFR 820.30, and EU MDR across the software life cycle.

You will author and review QMS documents, support regulatory submissions and audits, lead CAPA activities, and collaborate with cross‑functional teams to drive quality improvements, cybersecurity considerations, and