Built and managed a high-performing, team of 25 professionals across the US and Malaysia, overseeing the compliant design, verification, validation, and manufacturing of an innovative at-home in vitro diagnostic product. • Reduced software verification testing duration by 3 months (50% reduction) through the automation of 1,000+ test scripts, improving overall team productivity and project timelines.• Spearheaded in-house clinical sample management for 6,000+ samples in 3 clinical studies, cutting costs by $100K by eliminating outsourcing and streamlining internal processes.• Established a supplier management program that included CAPA processes, metrics tracking, and structured agreements, resulting in a 50% reduction in communication time with contract manufacturers.• Assembled a QA Operations team to handle calibration, maintenance, and testing (clinical, chemical, mechanical) for materials and products; implemented improved documentation and dashboards, reducing overdue calibration to <5% and increasing testing efficiency by 50%.• Developed a compliant training system for 140 employees, incorporating on-the-job training and quizzes across 100+ SOPs, achieving over 90% training compliance.• Redesigned document control workflow, improving consistency and reducing release times to under 10 minutes per document, supporting 25 weekly changes on average• Led configuration and validation of multiple enterprise systems (EDC, document control, training management, ERP, automated verification testing), reducing validation time by 50% and saving over $100K.

Brought on to lead the 510(k) submission for an ultrasound product, establishing robust design control, V&V testing, risk management, and quality management systems, culminating in successful FDA clearance. • Established a compliant quality management system with controls for design, training, change, documentation, supplier management, and regulatory reporting, securing ISO 13485, MDSAP, and CA State FDB certification. • Established a strong relationship with a tier-1 contract manufacturer, ensuring smooth design and manufacturing transfer; provided expertise on FDA process validation, resulting in a successful product launch. • Launched a non-conformance and CAPA program that drove cross-functional root cause investigations, resulting in a notable reduction in recurring issues from contract manufacturers. • Engineered a complete solution for the Design History File, organizing over 200 design inputs and verification reports, optimizing the FDA submission process.• Implemented a closed-loop complaint program to streamline regulatory reporting assessments, root cause analysis, and corrective feedback into design and manufacturing processes. This initiative improved issue resolution efficiency and ensured proactive mitigation of recurring problems.

• Designed and implemented quality systems in compliance with 21 CFR 820, ISO 13485• Guided company on software development practices for mobile application, cloud infrastructure, and embedded device firmware to achieve compliance with 21 CFR 820, FDA Software development guidance, and ISO 62304• Implemented computerized systems for the management of design history file and quality management systems in compliance with 21 CFR Part 11• Instituted supplier management program and collaborated with external contract manufacturers in establishing quality agreements

Led a quality team in achieving CE certification and FDA submission for an implantable neuromodulation device, overseeing compliant testing and release of clinical and commercial products across EU and US markets.• Optimized clinical quality operations by integrating adverse event reporting, complaint management, document control, and CRO coordination, improving compliance and cutting adverse event evaluation time by 25%. • Successfully managed FDA audits with no findings and sustained CE mark certification via consistent performance in notified body audits. • Served as lead auditor for clinical computerized systems suppliers (EDC, IVRS) and clinical research organizations. Identified critical non-conformances in suppliers' software development practices and implemented in-house mitigation strategies to ensure regulatory compliance and data integrity.

● Lead auditor for all critical raw material suppliers and Contract Manufacturing Organizations (CMOs).● Ensured timely resolution of product issues and investigations through effective communication with CMOs and suppliers.● Developed on the job training matrix for QC to leverage training on similar test methods and reduce the amount of on the job training required for QC. ● Established a cross functional team that developed supplier performance criteria and metrics used to generate supplier scorecards and provide consistent communication to suppliers. ● Provided the review and approval for all batch records, specifications, supplier agreements, and change notifications internally and with CMOs.● Refined document change control system to improve efficiency of the processing of documents; increased throughput to approximately 50 documents released in 4 hours with 1 FTE. ● Presented the management review and quality metrics to the executive team.

Created a team that oversaw all electrical, mechanical, software verification, and process validation for a combination medical device. Instrumental in the design, build-out, and validation of a Class 10k cleanroom, and led process validation initiatives for scaling from clinical to commercial manufacturing. • Developed and implemented comprehensive Validation Lifecycle Documentation, including validation project plans, requirements, functional specifications, design documents, impact and risk assessments, and IQ/OQ/PQ protocols for process equipment and corporate computerized systems. Established a streamlined validation system that improved process efficiency, cutting average validation time by 50%, from six months to three.• Led a cross-functional team in the successful transfer of product design and manufacturing processes to contract manufacturer. Collaborated closely with the partner, providing guidance to ensure process validation met FDA standards, resulting in a seamless and compliant technology transfer.• Represented quality in the selection and auditing of component manufacturers, ensuring compliance and quality standards for injection-molded plastics, printed circuit boards, and custom welded stainless steel components.