QMS Engineer (ISO 13485)

RecruitPedia Pte Ltd; Região Norte; Presencial; BRL 70 000 - 110 000; Tempo integral

Resumo da oferta

RecruitPedia Pte Ltd seeks a QMS Engineer for its manufacturing quality team in the North region of Brazil. The role focuses on establishing and maintaining the QMS in line with ISO 13485 and applicable regulations.

Key duties include managing controlled documents, coordinating internal audits, and driving process improvements. A diploma and 3 years of manufacturing quality experience with ISO 9001/13485 are required, plus internal auditor certification.

Qualificações

• 3 years of quality management experience in manufacturing.
• Experience with ISO 9001 and ISO 13485.
• Auditor certification required (internal auditor).

Responsabilidades

• Support implementation and maintenance of QMS per ISO 13485 and regulatory requirements.
• Manage controlled documentation and records.
• Plan and conduct internal audits and prepare audit reports.
• Improve QMS processes including document control and change management.
• Review quality documentation for regulatory alignment.
• Support management reviews and quality-related inquiries.
• Identify process improvements and drive corrective actions.
• Deliver quality training and communicate regulatory updates.

Conhecimentos

Quality mgmt systems

ISO 13485

ISO 9001

Internal Quality Auditor

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
• 3 years of quality management system experience in manufacturing industry
• Experience in both ISO 9001 & ISO13485
• Must be certified as Internal Quality Auditor for ISO 13485 / ISO 9001

We regret that only shortlisted candidates will be notified.