Maria is an accomplished Quality professional with a wealth of experience in quality management, engineering, and strategic leadership. Her skills include identifying opportunities for process improvement and implements strategies to enhance operational efficiency. This includes streamlining workflows, eliminating bottlenecks, reducing costs, and implementing best practices to drive productivity and quality.Her career is marked by a strong commitment to excellence, innovation, and transformative leadership. Maria's core strengths lie in executive-quality consultation and coaching (HIPAA compliance, FDA regulations, 21 CFR Part11, 820, IEC 62304), driving improvements throughout an organization, strategic planning, embracing innovation, process optimization, interpreting ISO standards and FDA regulations, and exemplifying transformational leadership. As a compliance expert, she has successfully navigated regulatory landscapes, ensuring the highest standards in the Life Science and Medical Device industries.As a thought leader, change agent, inventor, and innovator, I bring a wealth of experience in executive strategic consultation, with a focus on driving QMS transformation and enhancing operational efficiency. My expertise includes establishing metrics, key business processes, and procedures to ensure audit readiness for ISO 13485/9001 standards. I have collaborated deeply to solve complex business problems, influencing executive leadership on strategies related to quality, compliance, and marketing.My extensive experience encompasses Product Life Cycle Management and Design Control ISO 13485/ISO 9001, where I have successfully led high-visibility projects through the design control process, consistently exceeding customer expectations and prioritizing the Voice of the Customer (VoC). Notably, I managed and planned key quality activities for IBM projects at Watson Health, including spearheading the New Product Development Program for IBM Watson Health Life Sciences.In addition to my strategic contributions, I have designed and implemented innovative solutions such as a Quality and Compliance website for IBM Watson Health, placing quality at the forefront of operations. I have also created meaningful business assets to overcome compliance challenges, predicted client obstacles, and developed external informational assets for IBM's clientele to drive business growth.