Lead SaMD Quality Engineer: Digital Health & Compliance

BioSpace; North Chicago (IL); On-site; USD 130,000 - 170,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Short-term incentive program

Job summary

AbbVie is seeking a Lead Digital Health Quality Engineer to drive design controls, DHF management, software validation, and risk management across the software lifecycle for SaMD and Digital Health products.

The role leads QMS documentation, supports regulatory submissions, and collaborates with cross-functional teams to ensure compliance with global medical device regulations and IEC 62304 standards.

Qualifications

• Experience in a quality systems environment; strong analytical and communication skills.
• Strong cross-functional collaboration and problem-solving abilities.
• Familiarity with software medical device regulations and lifecycle requirements.
• Experience creating and maintaining QMS documents for medical devices.

Responsibilities

• Ensure compliance with corporate and global regulations governing Digital Health/SA MD software.
• Lead design controls and risk management activities per quality system requirements.
• Support regulatory submissions and CAPA activities.
• Drive continuous improvement in Design History File and Risk Management.

Skills

Quality Systems

Regulatory Knowledge

Cross-functional Collaboration

Analytical Thinking

Technical Writing

Education

Bachelor's degree with experience

Master's degree

PhD

Tools

QMS Documentation Tools

Regulatory Submissions Tools

Job description

AbbVie is seeking a Lead Digital Health Quality Engineer to drive design controls, DHF management, software validation, and risk management across the software lifecycle for SaMD and Digital Health products.

The role leads QMS documentation, supports regulatory submissions, and collaborates with cross-functional teams to ensure compliance with global medical device regulations and IEC 62304 standards.