Engenheiro da Qualidade

Products and Features Brasil; Nhandeara; Presencial; BRL 120 000 - 180 000; Tempo integral

Resumo da oferta

Products and Features Brasil is seeking a Quality Engineer to support development, manufacturing, and quality control of implantable medical devices. You will ensure QMS compliance with ISO 13485, MDSAP, FDA, and ANVISA, and collaborate with R&D, regulatory affairs, operations, and post-market teams.

The role emphasizes reviewing design deliverables, maintaining technical documentation, and participating in audits and validations to ensure product quality and patient safety.

Qualificações

• Bachelor's degree in Engineering or related field required.
• Postgraduate degree in Quality, Regulatory Affairs, or Medical Devices is desirable.
• Lean Six Sigma Green Belt or Black Belt is a differentiator.
• Minimum 5 years of quality experience in medical devices, pharma, or biotech.
• Experience with ISO 13485, MDSAP, FDA QSR, MDR, and ANVISA.

Responsabilidades

• 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 traceability and compliant documentation.
• Ensure all development deliverables meet QMS requirements and international standards.
• Technically evaluate customer complaints and support CAPA and regulatory notifications.
• Support MDR, FSCA, and ANVISA submissions and collaborate with post-market teams on regulatory responses.
• Review and approve process validation protocols (IQ, OQ, PQ) and equipment qualifications.
• Participate in risk management, FMEA updates, and design history/file documentation.
• Serve as quality focal point during audits (MDSAP, ISO 13485, MDR, ANVISA, FDA).

Conhecimentos

Quality engineering

Regulatory compliance

Documentation control

Auditing

Formação académica

Bachelor's degree in Engineering

Postgraduate in Quality/Regulatory/Medical Devices

Descrição da oferta de emprego

Quality Engineer

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.

Requirements

• 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.