Marcus Wilkes

Quality Assurance Manager @Boyd Industries, Inc.

Clearwater, FL, US

Oversee and ensure that Boyd’s Quality Management System complies with ISO 13485, FDA regulations (21 CFR Part 820), and other applicable standards, including audits, management reviews, and documentation. Develop and maintain quality policies and procedures.Serve as company point of contact for quality and regulatory audits including FDA, ISO, Intertek/UL and other similar agencies.Lead CAPA activities and process coordination for product issues, leveraging resources for failure analysis. Drive CAPA improvement projects across the company and with external suppliers.Serve as product development Quality Assurance Lead to ensure projects meet defined process requirements of FDA, ISO13485 and international standards. Manage technical information document control for regulatory submissions of medical devices. Collaborate with sales order management team to assure the timely and accurate processing of sales orders and customer requests. Develop and implement quality KPIs, analyze data using statistical methods, and report trends, issues, and improvements to management.Oversee failure analysis from MRB, production, engineering, technical services, and QC to identify root causes and recommend design or process changes. Collaborate with product engineering to analyze warranty claims, determine root causes, and document findings.Establish supplier quality requirements; develop, execute, and report on test processes and equipment needed for effective product/component evaluations and approvals.

Southern Polytechnic State University

Master of Science, Quality Assurance

Valparaiso University

Master of Science, Health Care Administration

North Carolina Agricultural and Technical State University

Bachelor of Science, Manufacturing Systems Technology