Senior Quality Engineer, Software Validation
Core
Subject-matter expert and process owner for production and non-product software validation in a regulated manufacturing environment, ensuring software and documentation meet quality and regulatory requirements.
Role type
Senior Quality Engineer, Software Validation
Builds
Production and non-product software validation strategies, protocols, test results, and lifecycle documentation for manufacturing, inspection, and test systems.
Domain
Medical device manufacturing / Software Validation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Software validation, Computer system validation, Risk management, Root cause analysis, Technical writing, Stakeholder management, VBA programming, Regulatory compliance
Preferred skills
Medical device industry experience, LabVIEW, Programmable logic controllers, Manufacturing execution systems, Cross-functional leadership, Global governance council participation
Technologies
VBA, LabVIEW, Programmable logic controllers, Manufacturing execution systems
Responsibilities
Lead and manage software-quality and validation requests from cross-functional teams; Develop, review, maintain, and approve software specifications and lifecycle documentation; Support development and execution of validation protocols and testing; Investigate software-quality and compliance issues including CAPAs and deviations; Assess software-related risk-management activities; Provide technical guidance on software lifecycle controls and compliance.
Seniority
Senior, hands-on IC
