Quality Engineer – ISO 13485 Medical Devices

About the role

We are seeking a Quality Engineer to join our team in a highly regulated ISO 13485 environment. The role will support quality assurance, regulatory compliance, and continuous improvement across our distribution and operational networks.

Key responsibilities

• Support quality assurance programmes, procedures and controls for medical devices and finished goods.
• Plan, coordinate and implement change controls, assessing quality and regulatory impact.
• Collaborate with Manufacturing Engineering and Operations on risk assessments, process improvements and quality initiatives.
• Lead investigations of non‑conformances, CAPAs and quality system issues, performing root‑cause analysis and corrective actions.
• Monitor quality performance trends using statistical tools and drive improvement projects.
• Support validation activities, including strategy development, sampling plans and execution for new and existing product lines.
• Ensure ongoing compliance with ISO 13485, QMS and applicable regulatory requirements.
• Identify potential quality and compliance risks and support mitigation activities.

Required profile

• Bachelor’s degree in Engineering, Science or a related discipline.
• 3‑5 years of experience in a regulated medical‑device environment.
• Strong knowledge of ISO 13485 and Quality Management Systems.
• Experience managing change controls, CAPA investigations and non‑conformance processes.
• Familiarity with risk management tools such as FMEA.

Required skills

• ISO 13485
• Quality Management Systems (QMS)
• CAPA management
• FMEA
• Root cause analysis
• Statistical analysis tools
• Microsoft Excel, Word and PowerPoint