Software Quality Engineer
Core
Lead software validation activities and architect enterprise applications for manufacturing execution and quality management systems in regulated environments.
Role type
Senior Software Quality Engineer (Validation)
Builds
Validated enterprise integration systems and applications for manufacturing brands
Domain
Manufacturing / Life Sciences / Regulatory Compliance (FDA 21 CFR)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GAMP categorization, Computer System Validation (CSV), 21 CFR Part 11, risk-based validation, test design and execution, defect management, validation documentation, Software Lifecycle (SLC) management, CAPA investigations, IQ/OQ/PQ protocols
Preferred skills
Manufacturing Execution Systems (MES), Enterprise Resource Planning (ERP), Quality Management Systems (QMS), FDA regulations, Good Documentation Practices (GDP)
Technologies
Enterprise Integration Systems, MES, ERP, QMS
Responsibilities
Lead validation strategy, planning, design, execution, and reporting; Architect and design enterprise applications; Coordinate defect triage and resolution; Develop Validation Master Plans (VMPs) and validation protocols; Review validation reports for compliance; Support CAPA investigations; Monitor solution stability and process improvements.
Seniority
Senior, hands-on IC
