Sr Quality Engineer – Post Market Surveillance (Medical Device)

Title: Senior Quality Engineer – Post Market Surveillance (Medical Device)Location: Naples, FLType: Contract-W2Key Requirements:• 8+ years of experience in medical device quality engineering, with strong expertise in complaint handling, product surveillance, and regulatory compliance (ISO/FDA).• Hands-on experience in root cause analysis, CAPA, nonconformance reporting, and statistical data analysis/trending.• Strong knowledge of medical device complaint investigation, adverse event reporting, and risk management processes.• Experience collaborating cross-functionally and supporting audits (FDA, Notified Body) with strong documentation and stakeholder communication skills.