Lead the charge in Quality Management System compliance and CAPA processes, driving complex investigations and audits while fostering cross-functional collaboration and coaching. Ensure effective risk assessments and sustainable improvements for quality.
Drive compliance in medical device standards using AI tools and independent engineering judgment. Collaborate with cross-functional teams to manage assessments, verify outputs, and facilitate decision-making processes within defined workflows.
Transform quality assurance by leading advanced internal audits to enhance compliance across cardiac assist operations. Drive improvements and coach auditors for regulatory excellence while ensuring readiness for external inspections.
Champion customer service excellence by leading a dedicated team. Drive improvements, manage KPIs, and enhance employee training. Be the point of resolution for client inquiries while fostering a collaborative work environment.
Lead the charge in overseeing clinical studies to enhance organ preservation through innovative research and management strategies, ensuring compliance and data integrity across multiple protocols and sites.