Lead SaMD & Digital Health Quality Engineer

BioSpace

North Chicago (IL)

On-site

USD 120,000 - 170,000

Full time

2 days ago

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Benefits offered by this job

PTO

Medical insurance

401(k)

Job summary

AbbVie in the United States is seeking a Lead Digital Health Quality Engineer to drive design controls, DHF management, software validation, and risk management (IEC 62304/ISO 14971) across the Software Life Cycle for SaMD and Digital Health products.

You will author, review, and approve QMS and project documentation, support regulatory submissions and audits, lead CAPA activities, and collaborate across cross-functional teams to ensure development and release in compliance with global

Qualifications

Bachelor's degree with 6+ years experience or Master’s with 5+ years or PhD with 0 years.
Experience in quality systems environment and cross-functional collaboration.
Strong understanding of IEC 62304, ISO 14971, 21 CFR 820.30 and EU MDR.
Experience creating and maintaining QMS documents for medical devices.

Responsibilities

Ensure compliance with policies, procedures, and global regulations for Digital Health apps and SaMD.
Perform design control and risk management activities per Quality System.
Lead and participate in continuous improvement, CAPA, audits, and regulatory support.
Lead and write processes and documentation for SaMD and Digital Health products.