Training Specialist

Leveraged a strong understanding of risk management, including Hazards Analyses, Patient Risk, Regulatory Risk, and Business Risk, while preparing medical startup Vista DME for BOC accreditation (for medical equipment suppliers – DME). Collaborated closely with the BOC auditor to prepare comprehensive documentation and address inquiries for follow-up audits. Successfully managed external audits of the accreditation process by developing detailed CAPA plans for nonconformities and ensuring adherence to critical quality standards. Streamlined operations and closed identified gaps by preparing and implementing new SOPs for Customer Service, Financial, and Sales departments, coupled with comprehensive training for staff, in compliance with ISO 13485 (Medical Devices Quality Management Systems), ISO 9001 (Quality Management Systems), FDA QSR, MDSAP, and EU MDR 2017/745 (CMDR). Facilitated the resolution of complex quality, technical, and financial issues through effective cross-functional collaboration with Finance, IT (front-end and back-end), Sales, and Customer Service departments, utilizing CRM and Business Central. Utilized Microsoft Business Central (MBC) to develop key operational metric reports for management, while also ensuring data integrity through precise SKU additions and timely resolution of incorrect descriptions within the system. Maintained accurate SKU item lists and performed data analysis within MBC for two medical businesses, Pivotal Med Supply and Vista DME. Ensured data integrity and a stable connection with CRM for the correct functioning of Customer Service, Finance, Sales, and IT departments. Actively engaged with external auditors during unexpected onsite audits and via email correspondence, ensuring timely provision of documents for BOC accreditation. Managed comprehensive documentation of major supplier adjustments, utilizing the established change request, QNC, or CAPA process. Prepared manuals, procedures, patient records, and financial documents, incorporating all quality system elements, root cause analysis, corrective action, and continuous improvement principles. Drove ongoing improvements in the Supplier Quality Management Process, guaranteeing adherence to all regulatory requirements. Implemented and optimized continuous improvement methodologies, leading to measurable enhancements in operational performance and compliance. Delivered technical expertise to effectively resolve intricate quality issues, facilitating the team’s root cause analysis investigations. Ensured compliance with all risk management requirements.

Developed and delivered comprehensive training programs for 800+ users, significantly enhancing their proficiency in Nobel Biocare intra-oral scanners and DTX Studio software and driving a 21% increase in productivity. Successfully led 500+ remote equipment and software deployments, ensuring seamless integration and smooth workflows for senior management and clients. Resolved 300+ warranty claims, increasing customer satisfaction and loyalty by 20%. Successfully addressed 95% of warranty claims within 24 hour deadline, demonstrating exceptional customer service. Led comprehensive training programs while mentoring new team members, providing personalized guidance and training to accelerate their professional development in digital dentistry.

Ensured strict adherence to company policies, standards, and regulations, including ISO 13485. Safeguarded brand reputation by effectively resolving medical device complaints, facilitating $1.7 million in credit notes and providing timely responses, including prompt submissions to the finance department for efficient credit note issuance and expense justification. Conducted thorough cross-functional investigations based on customer complaints, gathering evidence to support legal cases and proceedings involving fraud. Demonstrated expertise in managing complex claims investigations from initiation to closure, ensuring comprehensive and accurate documentation. Developed and implemented efficient claims review processes, reducing errors and improving operational efficiency across functional teams. Facilitated comprehensive training initiatives to enhance team knowledge and skills, fostering a culture of continuous improvement. Successfully coordinated settlement meetings with customers and senior representatives, negotiating favorable outcomes. Implemented strategies to mitigate damages and minimize losses, protecting company assets. Accurately documented and reported on all claim activities, ensuring compliance with company standards and regulatory requirements. Contributed to the development and implementation of robust quality management systems and procedures. Streamlined complaint resolution for 7 medical device businesses by designing and implementing a comprehensive management system, resulting in a 33% reduction in claim follow-up time. Developed an efficient customs documentation system to expedite the return process for defective products, identifying root causes of defects to prevent future occurrences. Established strategic partnerships with manufacturers across 5 global locations, escalating critical issues to relevant stakeholders worldwide for timely resolution. Possess extensive experience analyzing legal documents and medical records to accurately assess damages. Utilized industry-standard claims tools and software to assess damages effectively.

Identified root causes and implemented effective corrective and preventative actions (CAPA) for 7 medical device businesses, resulting in a 9% improvement in product quality. Spearheaded seamless internal and external audits, providing data-driven insights to support informed decision-making. Ensured strict adherence to FDA regulations and other relevant standards for medical devices, minimizing risks and maintaining regulatory compliance. Successfully trained 600+ clients and employees on compliance procedures through various engaging communication methods, fostering a culture of compliance. Established and implemented efficient processes and procedures in the TruVault document management system, streamlining operations and improving data accessibility. Maintained a robust quality management system (QMS) in accordance with ISO 13485 standards for a medical devices division, ensuring product quality and regulatory compliance. Created and implemented key performance indicators (KPIs) to measure product quality, process efficiency, and customer satisfaction, driving continuous improvement. Introduced and implemented 16 department-specific training programs (LMS) for 450+ employees, collaborating with senior leadership and maintaining the LMS with daily updates (tests, e-books, presentations, videos). Successfully managed change control procedures, minimizing risks and ensuring compliance with regulatory requirements. Designed and implemented effective CAPA plans to address quality issues and prevent non-conformances.