Thirteen years at FDA,
including eleven at the Center for Devices and Radiological Health.
Oliveri Consulting works with
medical device companies on quality and regulatory work,
and with government and commercial organizations on
Lean Six Sigma and process improvement.
Services
Quality Management System Development
Quality management system development and remediation under 21 CFR Part 820/QMSR and ISO 13485, including document control, CAPA procedures, training records, supplier controls, and management review. For example, consolidated more than 100 SOPs into a single unified quality framework for CDRH’s Office of In Vitro Diagnostics.
Regulatory Inspection Readiness
Mock inspections, gap assessments, and preparation sessions for staff at all levels, including FDA Quality System Regulation and ISO audit requirements. For example, conducted mock and red-team audits for CDRH organizations preparing for ISO 9001:2015 certification.
Process Improvement (Lean Six Sigma)
Lean Six Sigma and Agile process improvement for regulatory and operational work, including submissions, complaint handling, and CAPA closure. For example, facilitated the team that reduced Early Alert time for potential Class I Recalls from 30 days to approximately 10 days.
Software Quality and Digital Health
Quality assurance for software as a medical device (SaMD), including IEC 62304 software lifecycle compliance, design controls, and verification and validation. For example, established and led the only ISO 9001:2015-certified software group at FDA CDRH.
Lean Six Sigma Training
Green Belt and Black Belt certification training for government and commercial organizations, including curriculum design and program development. Established TSA Operations’ first LSS training program, growing it to $30M annually across 130+ airports. Trained over 300 Green Belts at Lockheed Martin Transportation and Security Solutions.