Provides quality engineering support for FDA-regulated manufacturing, including nonconformance investigations, root-cause analysis, CAPA, risk assessments, validation, quality systems, audits, calibration, and continuous improvement. The role analyzes quality metrics, develops specifications, supports regulatory compliance, evaluates process changes, and collaborates with Quality, Operations, Engineering, and suppliers to improve product and process performance.

Support manufacturing operations by leading process improvement and new product transfer projects. Perform root-cause analysis, validate tooling/equipment, develop standard procedures, manage vendor quotations, and apply CAD/3D modeling to improve efficiency, quality, and cost.

Lead Special Markets revenue growth for the Eastern region by expanding key accounts and acquiring new customers. Manage and coach sales and clinical teams, develop strategic plans, pricing and contract solutions, optimize HubSpot for forecasting, collaborate with Product and Marketing, and drive territory performance to meet targets. Requires travel and building executive-level customer relationships.