My technical expertise includes knowledge of Quality Systems and implementation, where I direct all aspects of developing and maintaining systems to achieve ISO 13485 and medical device directives.In addition, as a project manager, I have more than eight years of experience leading and supporting major software technology integration and validation initiatives. Directs all aspects of software validation and development lifecycles, including requirements gathering, system specification, software development, testing, and final implementation of new systems to production environments. Establishes technology policies to maximize overall business and system performance.• Professional achievements include:• Managed software development and validation projects valued at more than $1 Million; achieved project schedule and scope goals for all assigned initiatives.• Coordinated and lead over 35 projects verification and validation activities obtaining on time, high-quality deliverables, efforts that resulted in a promotion to Project Manager after six months as a Software Validation and Verification Lead.• Led projects to handle software safety activities to meet IEC 62304 international standard and FDA requirements.