Lead Digital Health Quality Engineer
AbbVie
August 31, 2026
Remote friendly (North Chicago, IL)
United States
$96,500 - $183,500 USD yearly
IT
Responsibilities:
- Serve as representative on cross-functional SaMD and Digital Health software product development teams, driving design controls, DHF management, software validation, and risk management (ISO 14971) throughout the software life cycle.
- Author, review, and approve QMS and project documentation, including risk management files, to ensure products are developed, tested, and released per applicable SDLC procedures and medical device regulations.
- Lead quality process improvement initiatives; support regulatory characterization and audits; contribute to cybersecurity quality activities using IEC 62304.
- Ensure compliance with corporate/divisional policies and global regulations for Digital Health applications and SaMD.
- Perform design control and risk management (including cybersecurity risk management), partner with technical teams, and ensure design change control/documentation requirements are met.
- Use Computer Software Assurance (CSA) and GAMP5 principles for software validation and lifecycle activities.
- Write/review processes and documentation for SaMD/Digital Health development; support regulatory submissions.
- Support CAPA (root cause analysis, effectiveness checks, closure); assist with regulatory agency and internal audits.
- Act as SME for SaMD/Digital Health quality and regulatory requirements; communicate project/quality status and recommend actions.
Qualifications (Required):
- Bachelor’s + 6 years; or Master’s + 5 years; or PhD + 0 years.
- Experience coordinating complex activities and solving complex problems; quality systems experience or equivalent; strong analytical judgment and communication; 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 device development.
Qualifications (Preferred):
- Familiarity with medical device cybersecurity; AI/ML; connected devices; Digital Health emerging technologies.
Benefits (if eligible): paid time off (vacation/holidays/sick), medical/dental/vision insurance, 401(k), and short-term incentive program eligibility.
- Serve as representative on cross-functional SaMD and Digital Health software product development teams, driving design controls, DHF management, software validation, and risk management (ISO 14971) throughout the software life cycle.
- Author, review, and approve QMS and project documentation, including risk management files, to ensure products are developed, tested, and released per applicable SDLC procedures and medical device regulations.
- Lead quality process improvement initiatives; support regulatory characterization and audits; contribute to cybersecurity quality activities using IEC 62304.
- Ensure compliance with corporate/divisional policies and global regulations for Digital Health applications and SaMD.
- Perform design control and risk management (including cybersecurity risk management), partner with technical teams, and ensure design change control/documentation requirements are met.
- Use Computer Software Assurance (CSA) and GAMP5 principles for software validation and lifecycle activities.
- Write/review processes and documentation for SaMD/Digital Health development; support regulatory submissions.
- Support CAPA (root cause analysis, effectiveness checks, closure); assist with regulatory agency and internal audits.
- Act as SME for SaMD/Digital Health quality and regulatory requirements; communicate project/quality status and recommend actions.
Qualifications (Required):
- Bachelor’s + 6 years; or Master’s + 5 years; or PhD + 0 years.
- Experience coordinating complex activities and solving complex problems; quality systems experience or equivalent; strong analytical judgment and communication; 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 device development.
Qualifications (Preferred):
- Familiarity with medical device cybersecurity; AI/ML; connected devices; Digital Health emerging technologies.
Benefits (if eligible): paid time off (vacation/holidays/sick), medical/dental/vision insurance, 401(k), and short-term incentive program eligibility.