**Descrição**:
Professional with solid experience in Quality Management Systems (QMS) in a regulated medical device company. Works independently in conducting critical activities in compliance with national and international regulations (ANVISA, ISO 13485, MDSAP, MDR, FDA), supporting the implementation and maintenance of quality systems. Participates in product development projects under Design Control, risk analysis, internal and external audits, and actively contributes to committees such as Change Control and MRB. Works in supplier management, CAPA control, continuous improvement support, and technical training, with a focus on the safety and efficacy of implantable medical devices.
- Quality Management System (QMS)
- Works in compliance with ISO 13485, MDR, RDC 751/2022, RDC 665/2022, and MDSAP
- Participates in executing and maintaining quality processes under supervision
- Supports alignment between local and global quality systems
- Aids in periodic effectiveness assessments and continuous-improvement initiatives
- Document & Record Control
- Operates eDMS, ensuring basic data integrity and traceability
- Helps draft and revise technical documents and quality records
- Participates in internal audits focusing on document governance
- Training Management
- Executes training control activities based on competency matrix
- Conducts impact analyses of operational changes on mandatory trainings
- Supports LMS management and ensures timely training record updates
- Change Management
- Serves as a contributing member in the Change Control Board discussions
- Performs initial impact assessments and drafts supporting documents for regulatory submissions
- Assists in meeting implementation deadlines
- CAPA
- Conducts medium complexity deviation investigations using structured methods
- Supports development and monitoring of CAPA plans and effectiveness indicators
- Analyzes trend data to prevent recurrence
- Metrics & Management Review
- Consolidates and presents QMS performance data
- Contributes to preparation of reports for Management Review
- Supports definition of risk-based corrective actions
- Design & Development
- Participates in the project team as Quality liaison
- Reviews design control documentation and provides technical feedback
- Supports release of DMR/DHF and resolution of design-transfer nonconformities
- Equipment, Calibration & Maintenance
- Assists in controlling and tracing critical instruments
- Helps develop maintenance/calibration schedules
- Verifies compliance of service provider certificates
- Supplier Management
- Participates in qualification and monitoring of critical suppliers
- Supports supplier audits and SCAR follow up
- Compiles data for supply chain performance indicators
- Audits
- Helps prepare and conduct internal audits per annual plan
- Assists with logístical support during external audits
- Monitors and follows up on corrective actions
- Material Review Board (MRB)
- Participates in MRB meetings and prepares technical reports for disposition decisions
- Assists with analysis of technical deviations
- Ensures proper documentation and filing of MRB decisions
- Engineering & Risk Management
- Works with Manufacturing Engineering on validations and in-line controls
- Helps maintain RMF per ISO 14971
- Participates in risk review sessions and post market activities
Profissional com sólida experiência no Sistema de Gestão da Qualidade (SGQ) em empresa de dispositivos médicos regulada. Atua com autonomia na condução de atividades críticas de conformidade com regulamentações nacionais e internacionais (ANVISA, ISO 13485, MDSAP, MDR, FDA), apoiando a implementação e manutenção de sistemas de qualidade. Participa de projetos de desenvolvimento de produtos sob Design Control, análises de risco, auditorias internas e externas, além de contribuir ativamente em comitês como Change Control e MRB. Atua na gestão de fornecedores, controle de CAPAs, suporte à melhoria contínua e na condução de treinamentos técnicos, com foco na segurança e eficácia de dispositivos médicos implantáveis.
- Sistema de Gestão da Qualidade (SGQ)
- Atua em conformidade com ISO 13485:2016, MDR 2017/745, RDC 751/2022, RDC 665/2022 e MDSAP;
- Participa da execução e manutenção dos processos da qualidade sob supervisão;
- Colabora para o alinhamento entre sistemas locais e globais de qualidade;
- Apoia avaliações periódicas de eficácia do SGQ e iniciativas de melhoria contínua.
- Controle de Documentos e Registros
- Opera o sistema eletrônico de controle de documentos (eDMS), assegurando rastreabilidade e integridade básica de dados;
- Dá suporte na elaboração e revisão de documentos técnicos e registros da qualidade;
- Participa de auditorias internas com foco na governança documental.
- Gestão de Treinamento
- Executa atividades de controle de treinamentos com base na matriz de competências;
- Realiza análises de impacto de mudanças operacionais sobre treinamentos obrigatórios;
- Apoia a gestão do sistema