Kforce has a client in Irvine, CA that is seeking a Senior Design Assurance Quality Engineer. Responsibilities: * Supporting electrode product and process sustaining activities through the application of Quality engineering skills for medical devices * Focuses on process, equipment, and design verification and validations * Working with teams to develop manufacturing and quality processes and define their related tools * Troubleshooting and support of manufacturing floor and field issues, and review and approve validations * Review and approve verification and validation protocols and reports * Participate in Change Control review and approval activities as required * Provide technical guidance and oversight to Quality Engineers * Participate in Risk Management process, including the development and maintenance of risk management files, ensuring compliance with ISO 14971 * Develop and implement quality plans * Ensure post market surveillance reviews are conducted and reports documented according to schedule * Participate in CAPA efforts, and apply systematic problem-solving methodologies identifying, prioritizing, communicating, and driving resolution of quality issues * Provide key quality trending information and data for Management Review and monthly KPI review, as applicable * Represent quality interests and concerns on project teams * Investigate causes of quality and yield problems identified in the field and throughout the manufacturing and testing processes * Provide critical quality engineering direction to projects with respect to generally accepted quality engineering tools/principles, such as process validation, equipment, test methods, root cause analysis, risk mitigation, process improvement tools, sampling plans, etc. * Provide support during regulatory audits and responses to government agency questions