Quality Assurance Engineer

About the role

We are seeking a Quality Assurance Engineer to support the implementation and continuous improvement of our Quality Management System (QMS) in a medical‑device environment. The role ensures compliance with ISO 9001 and ISO 13485 standards and drives process excellence across the organization.

Key responsibilities

• Develop, implement and maintain the QMS in line with ISO 9001 and ISO 13485 requirements.
• Maintain and control all quality documentation, ensuring it is up‑to‑date and readily accessible.
• Plan, execute and report internal audits; coordinate external audits and certification activities.
• Identify non‑conformities, lead corrective and preventive actions (CAPA), and verify their effectiveness.
• Analyze processes, define KPIs, and lead continuous‑improvement projects using Kaizen, Lean or Six Sigma methodologies.
• Deliver training on ISO standards and QMS procedures, raising employee awareness of quality policies.
• Monitor customer feedback, manage complaints, and implement corrective actions based on satisfaction data.
• Conduct risk assessments, develop mitigation plans, and integrate business‑continuity considerations into quality processes.
• Collaborate with HR, operations, supply chain and management to align quality objectives with business goals.

Required profile

• Bachelor’s degree in Industrial Engineering or a related field.
• Minimum 4 years of relevant experience, preferably in the medical sector.
• Strong knowledge of ISO 9001; familiarity with ISO 13485 is a plus.
• Certified Internal Auditor or Lead Auditor preferred.

Required skills

• ISO 9001
• ISO 13485
• Internal Auditor certification
• Lead Auditor certification
• CAPA management
• Kaizen
• Lean
• Six Sigma
• Risk assessment