Analista da Qualidade

Map processes, plan, develop, and implement tools for quality management system control to ensure compliance with medical device manufacturing best practices and ISO 13485 standards. Conduct third-party audits, manage statistical process control and measurement system analysis, and oversee equipment monitoring and management. Execute first- and second-party audits, create inspection exams in the computerized system, and lead process validation activities. Control management indicators, change control plans, and all corrective, preventive, and improvement actions. Draft, revise, and distribute quality system documents while ensuring obsolete item disposal. Deliver training sessions to foster an operational excellence culture.