The Lead Digital Health Quality Engineer will 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. This role will Author, review, and approve QMS and project documentation — including risk management files — to ensure products are developed, tested, and released in compliance with applicable SDLC procedure and/or medical device regulations. This role will lead quality process improvement initiatives, support regulatory characterization and audit, and contribute to cybersecurity quality activities, applying IEC 62304 and strong technical writing and cross-functional collaboration skills.
Responsibilities:
- Responsible for compliance with applicable Corporate and Divisional policies, procedures, and global regulations governing Digital Health applications and SaMD, including AbbVie's software lifecycle requirements, using standard methodologies, processes, and tools.
- Perform design control and risk management activities (including cybersecurity risk management) per AbbVie's Quality System, partnering with technical teams to ensure design control documentation (risk management, traceability/linkages) and design change control requirements are met.
- Experience with Computer Software Assurance (CSA) and GAMP5 principles for software validation and lifecycle activities.
- Write/review processes, procedures, and related documents for the development of SaMD and Digital Health products in compliance with global regulations.
- Support the creation of regulatory submission documentation.
- Support Corrective and Preventive Action (CAPA) activities related to SaMD and Digital Health quality issues, including root cause analysis, effectiveness checks, and closure.
- Assist in the preparation of, and support, regulatory agency and internal audits.
- Lead and actively participate in continuous improvement initiatives — including within the Design History File and Risk Management — anticipating and resolving quality issues, taking preventative action, and tracking improvements to closure.
- Serve as a subject matter expert on SaMD/Digital Health quality and regulatory requirements across cross-functional teams.
- Communicate SaMD/Digital Health project and quality status through timely, accurate reports to project teams, and management, and recommend actions to resolve emerging issues.
- Initiate assignments independently, exercising considerable latitude in determining objectives and approach.