Charles Young

Supported strategic QMS and management-controls workstreams, coordinating governance, actions, accountable owners, and improvement deliverables. Aligned stakeholders across functions to strengthen documentation, escalation, and sustainable quality-system execution.

Supported supplier-quality oversight and performance activities, collaborating with cross-functional stakeholders to identify risk, investigate issues, and advance corrective actions. Contributed to supplier performance management and compliance-focused improvements in a regulated life-sciences environment.

Led quality assurance within regulated manufacturing/distribution operations, supporting investigations, nonconformance management, compliance, and audit preparedness. Partnered with operations and quality stakeholders to address recurring issues and improve process discipline and control effectiveness.

Led quality-program coordination across integration, divestiture, and QMS alignment activities; helped manage compliance risks and controlled-state transitions. Coordinated cross-site milestones, governance decisions, issue escalation, and remediation actions with Quality, Operations, Regulatory, and Supply Chain.

Managed a global team of 21 Design Quality Engineers supporting 42 product families and approximately 2,000 SKUs; directed priorities and cross-functional quality execution. Partnered with R&D, Clinical, Regulatory Affairs, and Medical Safety on design controls, risk traceability, design FMEAs, and verification/validation evidence.

Supported engineering quality, investigations, validation, risk assessment, and medical-device regulatory quality activities. Earlier supplier-quality and automotive manufacturing roles included supplier audits, supplier development, APQP, PPAP, PFMEA, control plans, and corrective action.

Bachelor of Science in Electrical Engineering from Kettering University.