Principal Engineer, Quality - Automation and AI
Core
Ensuring IT operations and software lifecycle compliance with regulatory requirements through AI-driven automation and digital enablement.
Role type
Principal Quality Engineer (Automation and AI)
Builds
Automated quality monitoring systems, audit readiness solutions, and digital compliance workflows.
Domain
Life Sciences / Regulated Software Development
Deliverable
production ML models | infrastructure | dashboards & analysis
Required skills
AI/ML solutions, DevOps toolchain, automation, pipeline technologies, workflow optimization, regulatory auditing, CAPA execution, risk management, SLC monitoring, data analytics, cross-functional process improvement.
Preferred skills
Life sciences industry experience, US GMP regulations (21 CFR 11, 58, 210, 211, 820), ASQ CQA/CSQE certification, PMP, Six Sigma, supervisory experience.
Technologies
DevOps tools, automated dashboards, AI-powered solutions, data analytics platforms.
Responsibilities
Develop and champion solution strategies leveraging AI for compliance monitoring; apply DevOps expertise for technology-process integration; drive modernization of communications and metrics management; oversee SLC monitoring with automated alerts; serve as primary contact for quality events and root cause analysis; represent SQA in governance forums; manage internal and external audit support; provide mentorship and training on digital quality enablement; supervise documentation and evidence management; report on SQA metrics to drive insights.
Seniority
Principal, hands-on IC with strategic leadership
