Analista da Garantia da Qualidade Senior

Descrição:

Senior professional with critical and multifunctional experience in the Quality Management System (QMS) of a highly regulated medical device organization. Acts as a technical and strategic authority on quality, with responsibility for maintaining compliance with national and international regulations (ANVISA, MDR, ISO 13485, MDSAP, FDA). Leads the implementation of robust quality systems, product development under Design Control, risk management, and regulatory audits. Represents Quality on decision-making committees (Change Control, MRB, Management Review), ensures excellence in supplier management, CAPAs, continuous improvement processes, and critical training to ensure the safe and effective performance of implantable medical devices.

• Quality Management System (QMS)

o Acts as technical authority for the QMS in alignment with ISO 13485:2016, MDR 2017/745, RDC 751/2022, RDC 665/2022, and MDSAP

o Oversees execution and maintenance of all quality processes including document control, risk management, CAPA, and change control

o Ensures harmonization between local and global quality systems

o Leads periodic effectiveness assessments of the QMS and implements strategic continuous-improvement plans

• Document & Record Control

o Manages electronic document control system (eDMS), ensuring data integrity, electronic signatures, traceability, and compliance with 21 CFR Part 11

o Oversees technical and regulatory document structure: SOPs, quality records, work instructions, and technical product files

o Leads internal audits focusing on document governance and regulatory readiness

• Training Management

o Manages qualification and requalification processes based on a competency matrix

o Conducts impact analysis of document and operational changes on mandatory training

o Oversees the electronic training system (LMS), ensuring regulatory compliance and record integrity for inspections

• Change Management

• Serves as senior member of the Change Control Board, with decision making authority over technical, regulatory, and patient safety impact assessments

• Approves change packages with multidisciplinary impact analysis and updates to regulatory documents (e.g., Technical Files, DMR, DHR)

• Ensures compliance with regulatory timelines, including post change submissions and notifications

• CAPA – Corrective & Preventive Actions

o Leads high risk investigations using structured methodologies (RCA, 5 Whys, Ishikawa)

o Develops, approves, and oversees CAPA plans with assigned owners, timelines, and efficacy metrics

o Analyzes trends and recurrence to prevent systemic failures and ensure continuous improvement

• Metrics & Management Review

o Leads consolidation of quality KPIs and statistical performance analysis: CAPA lead time, rework, complaints, SCAR, document control compliance, training effectiveness

o Prepares technical and strategic content for Management Review meetings based on regulatory data (ISO 13485:2016 – clause 5.6)

o Proposes mid and long term action plans based on risk and compliance

• Design & Development (Design Control)

o Acts as Quality representative in the project team from concept phase through commercial release

o Reviews and approves design control deliverables: URS, PRD, design inputs/outputs, traceability matrix, product FMEA, V&V protocols/reports

o Technically releases the DMR and DHF for regulatory submissions and initial lot release

o Assesses nonconformities during design transfer and ensures technical/regulatory closure

• Equipment, Calibration & Maintenance

o Oversees calibration program in accordance with ISO 10012 and internal metrological criteria

o Validates and approves preventive and corrective maintenance schedules for critical equipment

o Audits suppliers of technical services (calibration/maintenance) and approves certificates

• Supplier Management

o Leads qualification and requalification of critical suppliers (QMS, product quality, lead time, nonconformity history)

o Conducts supplier audits (on site and remote) based on ISO 13485 and MDSAP

o Manages high criticality SCARs and monitors supply-chain performance indicators

• Internal & External Audits

• Plans, leads, and executes comprehensive internal audits according to annual plan and risk analysis

• Serves as audit host for ANVISA, FDA, Notified Bodies (CE/MDR), MDSAP, and strategic customers

• Coordinates formal regulatory responses to observations, CAPA follow up, and communication

• Material Review Board (MRB)

o Permanent MRB member with technical authority over disposition of nonconforming materials and products

o Conducts analyses based on technical criteria, deviation history, patient safety risk, and traceability impact

o Ensures robust documentation for release, rework, or scrap, with input into the DHR

• Interface with Engineering & Risk Management

o Acts as primary Quality liaison with Manufacturing Engineering

o Oversees process and equipment validations (IQ/OQ/PQ), layout reviews, in-line controls, and segregation of critical areas

o Manages Risk Management File (RMF) per ISO 14971 and ensures traceability between risks, controls, and validation

o Leads and facilitates risk review sessions, including post market (PMS, PSUR) and mitigation of newly identified risks

Profissional sênior com atuação crítica e multifuncional no Sistema de Gestão da Qualidade (SGQ) de uma organização de dispositivos médicos altamente regulada. Atua como autoridade técnica e estratégica em qualidade, com responsabilidade sobre a manutenção da conformidade com regulamentações nacionais e internacionais (ANVISA, MDR, ISO 13485, MDSAP, FDA). Lidera a implementação de sistemas robustos de qualidade, desenvolvimento de produtos sob Design Control, gerenciamento de risco e auditorias regulatórias. Representa a Qualidade em comitês decisórios (Change Control, MRB, Revisão da Direção), garante a excelência na gestão de fornecedores, CAPAs, processos de melhoria contínua e treinamentos críticos para assegurar desempenho seguro e eficaz de dispositivos médicos implantáveis.

• Sistema de Gestão da Qualidade (SGQ)

o Atua como autoridade técnica para o SGQ em alinhamento com ISO 13485:2016, MDR 2017/745, RDC 751/2022, RDC 665/2022 e MDSAP;

o Supervisiona a execução e manutenção de todos os processos da qualidade incluindo controle de documentos, gerenciamento de risco, CAPA e controle de mudanças;

o Garante a harmonização entre os sistemas locais e globais de qualidade;

o Lidera avaliações periódicas de eficácia do SGQ e implementação de planos estratégicos de melhoria contínua.

• Controle de Documentos e Registros

o Gerencia o sistema eletrônico de controle de documentos (eDMS), garantindo integridade de dados, assinatura eletrônica, rastreabilidade e compliance com 21 CFR Part 11;

o Supervisiona a estrutura documental técnica e regulatória: procedimentos operacionais padrão (POPs), registros da qualidade, instruções de trabalho e documentos técnicos de produto;

o Lidera auditorias internas focadas na governança documental e readiness regulatória.

• Gestão de Treinamento

o Gerencia o processo de qualificação e requalificação baseado em matriz de competências;

o Conduz análise de impacto de mudanças documentais e operacionais sobre treinamentos obrigatórios;

o Supervisiona o sistema eletrônico de treinamentos (LMS), garantindo conformidade com requerimentos normativos