Dean Sauerwine

Background

About Dean Sauerwine

I help global organizations in medical device (ISO 13485, FDA QSR, IVDR) and automotive OEM (ISO 9001, NHTSA/FMVS) industries transform regulatory compliance, customer feedback, and nonconformance data into KPI-driven quality systems that protect customers, improve performance, and reduce cost. My 25+ years expertise in medical device (ISO 13485, FDA QSR, IVDR) and automotive OEM (ISO 9001, NHTSA/FMVS) environments. is in transforming complex regulatory requirements into KPI-driven quality systems that improve compliance, reduce risk, and enhance customer trust. At both Illumina and Honda, I’ve led functions spanning complaint handling, nonconformance management, and customer feedback integration — leveraging structured CRM, lifecycle data, batch records, and software controls to create quality metrics that drive proactive decision-making. Key strengths include: • Complaint handling for field actions, adverse event monitoring, cybersecurity events • Nonconformance investigations for supplier-sourced and internal manufacturing issues • KPI frameworks integrating CRM, ERP, and QMS data for actionable reporting • Supplier return material analysis and corrective action effectiveness tracking • Customer safety communications and product notifications in regulated environments Select Achievements: • Led complaint handling through FDA, Notified Body, and NHTSA inspections • Reduced investigation cycle times by >30% via KPI automation and workflow optimization. • Delivered multi-million-dollar warranty and quality cost savings through supplier remediation and proactive market actions. Whether in a regulated medical device environment or the fast-paced automotive industry, I excel at aligning regulatory depth with operational excellence to deliver measurable quality improvements and safeguard customer trust.