QMS Engineer (IQA ISO13485)

RecruitPedia Pte Ltd; Região Norte; Presencial; BRL 60 000 - 120 000; Tempo integral

Resumo da oferta

RecruitPedia Pte Ltd's client, a leading manufacturing MNC in Brazil, seeks a QMS Engineer to join the Quality team on transformation projects. The role focuses on implementing and maintaining the QMS in line with ISO 13485 and regulatory requirements, driving audits and continuous improvement.

You will manage document control, support internal audits, deliver training, and assist in new operations deployments to ensure ongoing compliance and quality excellence across facilities.

Qualificações

• Minimum Diploma in relevant discipline.
• 2-3 years of quality management system experience in manufacturing.
• Experience in ISO13485 + ISO 9001.
• Must be Certified Internal Quality Auditors in ISO 13485 / ISO 9001.

Responsabilidades

• Support the implementation and maintenance of the Quality Management System (QMS) in accordance with ISO 13485 and relevant regulatory requirements.
• Manage controlled documentation, including procedures, work instructions, specifications, and technical records.
• Plan, coordinate, and conduct internal audits to ensure compliance and audit readiness.
• Maintain and improve QMS processes, including document control, change management, and system validation activities.
• Review and update quality documentation to ensure alignment with operational and regulatory standards.
• Prepare reports, maintain quality records, and support management review activities.
• Identify process improvement opportunities and drive corrective and preventive actions.
• Deliver quality-related training and communicate updates on quality and regulatory requirements.
• Support customer audits, external assessments, and quality-related inquiries.
• Assist in the deployment of QMS frameworks for new operations or facilities.
• Participate in internal auditing activities and support continuous compliance initiatives.

Conhecimentos

Quality management

Internal audits

Documentation control

Regulatory compliance

Process improvement

Formação académica

Diploma in relevant discipline

Ferramentas

ISO 13485/9001 knowledge

Descrição da oferta de emprego

Our client is a Manufacturing MNC, one of the leading players in the Contract Manufacturing sector. Due to business needs, they are now recruiting a QMS Engineer to be part of their Quality team for ongoing transformation projects. They are located in the North - easily accessible.

QMS Engineer

Duties of QMS Engineer:

• Support the implementation and maintenance of the Quality Management System (QMS) in accordance with ISO 13485 and relevant regulatory requirements.

• Manage controlled documentation, including procedures, work instructions, specifications, and technical records.

• Plan, coordinate, and conduct internal audits to ensure compliance and audit readiness.

• Maintain and improve QMS processes, including document control, change management, and system validation activities.

• Review and update quality documentation to ensure alignment with operational and regulatory standards.

• Prepare reports, maintain quality records, and support management review activities.

• Identify process improvement opportunities and drive corrective and preventive actions.

• Deliver quality-related training and communicate updates on quality and regulatory requirements.

• Support customer audits, external assessments, and quality-related inquiries.

• Assist in the deployment of QMS frameworks for new operations or facilities.

• Participate in internal auditing activities and support continuous compliance initiatives.

Requirements

• Minimum Diploma in relevant discipline

• 2-3 years of quality management system experience in manufacturing industry

• Experience in ISO13485 + ISO 9001

• Must be Certified Internal Quality Auditors in ISO 13485 / ISO 9001