Leads enterprise quality assurance and regulatory affairs as Sarnova expands into medical device manufacturing. Builds and maintains FDA- and ISO-aligned quality systems, oversees manufacturing and supplier quality, regulatory submissions, audits, inspections, design controls, post-market surveillance, recalls, and product lifecycle compliance. Partners across the organization on commercialization and acquisitions while developing the quality team, metrics, continuous improvement programs, and a strong culture of regulatory excellence.

Conduct internal and ad hoc audits of operational and manufacturing processes, identify nonconformities, document findings, and track corrective actions. Analyze quality trends and KPIs, maintain quality records, support external audits and regulatory inspections, provide quality training, and collaborate with operations, engineering, and management on process improvement and safety compliance.

Audit and review facility contracts and billing accuracy across systems, serve as primary contact for contractual billing issues, support acquisitions/transitions, track and correct DDF/IDX/TELCOR billing changes, perform monthly compliance audits, and manage ServiceNow ticketing and billing system operations to ensure accurate facility billing.