Senior Product Quality Assurance Engineer

Summary

The Senior Design Quality Engineer ensures digital health products comply with FDA regulations, quality standards, and user requirements through design controls and verification/validation activities. They manage digital health projects from concept to production using phase-gate approaches, lead or support CAPAs and NCRs, conduct internal/external audits, and apply risk management throughout the design lifecycle. The role requires advanced knowledge of FDA design controls and IEC 62304 software standards, with hands-on experience taking products through regulatory compliance. The engineer will work independently, provide executive guidance on quality matters, and serve as a best-practice resource within their area of expertise.