Quality and Regulatory Engineer
Core
Maintain compliance with ISO 17025, NQA-1, 10CFR 50 Appendix B, and ISO 9001 standards for nuclear grade quality assurance in biomedical and radiation detection products.
Role type
Quality and Regulatory Engineer
Builds
Quality Management Systems (QMS), validated manufacturing processes, and regulatory compliance documentation for medical devices and radiation monitoring equipment.
Domain
Healthcare technology / Radiation detection / Nuclear safety
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CAPA management, internal/external audit execution, risk analysis (FMEA, ISO 14971), supplier corrective action coordination, process validation (IQ/OQ/PQ), Six Sigma/Lean methodologies, data trending and analysis, complaint handling, regulatory standard interpretation.
Preferred skills
Radiation dosimetry experience, Certified Auditor status, GMP principles, New Product Introduction (FAI) and Design Transfer leadership.
Technologies
MS Office Suite, statistical analysis tools, QMS software platforms
Responsibilities
Maintain and improve the Quality Management System (QMS) per ISO 9001, ISO/IEC 17025, NQA-1, and 10 CFR 50 Appendix B; Chair CAPA meetings and lead corrective action efforts; Conduct internal audits and gap analyses; Coordinate Supplier Corrective Action Requests (SCAR); Execute New Product Introduction and Design Transfer activities including process validation; Analyze quality data and manage non-conformance investigations.
Seniority
Mid-level, hands-on IC