Non Product Software Validation Engineer
Core
Ensures product quality and regulatory compliance by implementing validation procedures, managing recalls, and overseeing supplier quality processes for manufactured products.
Role type
Senior Quality Validation Engineer (Regulated Industry)
Builds
Validated software systems and compliant manufacturing processes
Domain
Healthcare / Medical Devices / Regulated Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Computer System Validation (CSV), 21 CFR Part 11, ISO 13485, GAMP 5, Supplier Quality Management, Product Recall Management, Quality Management Systems (QMS), CAPA, Risk Management, KPI Monitoring
Preferred skills
People Management, Strategic Planning, Business Acumen, Continuous Improvement
Technologies
Automated technology for systems security and control
Responsibilities
Implement policy changes and operational frameworks; monitor operational KPIs; manage product recalls and regulatory compliance; guide and mentor the quality assurance team; organize material qualification and supplier process enhancement; collaborate with stakeholders on product development.
Seniority
Senior, hands-on IC with people management responsibilities