Kforce's client, a growing and established Medical Device Company is seeking a couple of Senior Design Quality Engineers for a long-term contract position in Costa Mesa, CA. We are working directly with the Hiring Manager on this search assignment. This position is hybrid remote. Responsibilities: * Responsible for supporting electro-mechanical 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 * Work with R&D every day to improve product designs * Any line down situations/production issues - change control to address design changes - work with engineering teams * Participate in Risk Management process, including the development and maintenance of risk management files, ensuring compliance with ISO 14971 * Working on the design and looking to come up with the right solutions (This position is more than just ensuring compliance and regulations) * 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 * 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.