Descrição
The Quality Engineer will be responsible for supporting the development, manufacturing, and quality control of implantable medical devices, ensuring that products and processes meet the quality and safety standards required by the market. He/she will work in partnership with areas such as R&D, Regulatory Affairs, Operations, Process Engineering, Supplies, and Post-Market, contributing to maintaining the quality management system (QMS) in compliance with regulatory standards and requirements, such as ISO 13485, MDSAP, FDA, and ANVISA. This professional will play an essential role in providing technical support to internal teams, reviewing documentation, and participating in audits and validations, helping to ensure product quality and customer and patient satisfaction.
1. Product Development and Deliverables
Act as the quality representative throughout all phases of the product development cycle (planning, design, verification, validation, and launch).Review and approve design deliverables and project evidence, ensuring consistent technical documentation and traceability.Ensure all development deliverables comply with QMS requirements and international standards.
2. Complaints and Post-Market Support
Technically evaluate customer complaint investigations and prepare closure reports to support CAPA and regulatory notifications.Support Medical Device Reports (MDR) for the FDA, Field Safety Corrective Actions (FSCA) for European authorities, and submissions to ANVISA.Collaborate with global post-market teams to align consistent technical responses.
3. Process Validation and Control
Review and approve process validation protocols and reports (IQ, OQ, PQ) in accordance with international standards and local regulations.Evaluate and approve equipment qualifications, inspection methods, and software used in medical device manufacturing.Support the implementation of continuous improvements in manufacturing processes to ensure reliability and consistency.
4. Change Management and Technical Documentation
Evaluate and approve change orders from a quality and regulatory compliance perspective.Ensure technical documentation meets Design History File (DHF), Device Master Record (DMR), and Technical File requirements.Prepare technical memoranda and formal responses for regulatory authorities as part of notification packages and during audits.
5. Risk Management and FMEA
Contribute to risk management throughout the product lifecycle.Review, update, and maintain product and process FMEAs in collaboration with R&D, manufacturing, and process engineering teams.Ensure identified risks are adequately addressed and corrective actions are documented and monitored.Support the integration of risk requirements into the Design History File (DHF) and product development processes.
6. Audits and Regulatory Compliance
Serve as the quality focal point during internal, external, and certification audits, including MDSAP, ISO 13485, MDR, ANVISA, and FDA inspections.
Requisitos
Education: Bachelor's degree in Engineering (Biomedical, Materials, Mechanical, Manufacturing, Electrical, Chemical, or related fields).Desirable: Postgraduate degree in Quality, Regulatory Affairs, or Medical Devices.Certifications/Training: Lean Six Sigma Green Belt or Black Belt training or certification will be considered an important differential.Experience: Minimum of 5 years in quality roles in the medical device, pharmaceutical, or biotechnology sector. Practical experience with ISO 13485, MDSAP, FDA QSR, MDR, and ANVISA.Knowledge of ISO, CFR, RDC Standards: Works to ensure the compliance of processes, products, and quality systems with national and international standards applicable to medical devices, ensuring regulatory adherence and continuous improvement.Quality Tools: Applies quality tools (FMEA, PDCA, 5 Whys, Ishikawa, statistical process control, among others) for failure analysis, process improvement, and non-conformity prevention.Advanced English: Ensures fluent communication in an international environment, including interpretation of standards, interaction with auditors, suppliers, and global teams, as well as the preparation and review of technical documentation.CAPA Investigations: Conducts investigations of deviations, non-conformities, and complaints, defining and monitoring corrective and preventive actions (CAPA), ensuring effectiveness and risk reduction.Quality Control Systems: Manages and maintains quality control systems, ensuring traceability, data integrity, monitoring of indicators, and compliance with regulatory and internal requirements.
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