QMS Engineer (ISO13485/Manufacturing)

RecruitPedia Pte Ltd; Região Norte; Presencial; BRL 60 000 - 90 000; Tempo integral

Resumo da oferta

RecruitPedia Pte Ltd in Brazil is seeking a QMS Engineer to join our Quality team for ongoing transformation projects. The role focuses on implementing and maintaining the Quality Management System (QMS) in accordance with ISO 13485 and applicable regulatory requirements, and managing controlled documentation, procedures, work instructions, specifications, and records.

You will plan and conduct internal audits, drive continuous improvements, support customer audits, deliver quality training, and

Qualificações

• Minimum Diploma in a relevant discipline.
• 2–3 years of quality management system experience in manufacturing.
• Experience in ISO13485.

Responsabilidades

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

Formação académica

Diploma in relevant discipline

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.

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

We regret that only shortlisted candidates will be notified.