Quality Assurance Engineer

About the role

The Quality Department is seeking a Quality Assurance Engineer to support the Quality Management System and supplier management activities. You will work closely with the Quality Manager and cross‑functional teams to ensure product quality and continuous improvement.

Key responsibilities

• Participate in supplier onboarding, selection, approval, and audit processes, including facility visits and quality agreement reviews.
• Evaluate and monitor supplier performance, identifying improvement opportunities.
• Support new supplier/material qualification, ensuring documentation completeness and material quality.
• Collaborate with external suppliers and internal stakeholders (Procurement, Warehouse, Manufacturing) on qualification projects and material quality issues.
• Address material failures/defects, develop preventive and corrective actions via the SCAR system.
• Implement inspection standards for incoming and outgoing goods.
• Close CAPA, non‑conformance investigations, and customer complaints, publishing quality performance reports.
• Lead Material Review Board meetings to conduct root‑cause analysis and verify corrective actions.
• Maintain ISO 9001, 14001, 13485 documentation and ensure readiness for audits and certifications.
• Plan and conduct internal and external audits, develop action plans, and drive continuous improvement.

Required profile

• Diploma in quality management, engineering, manufacturing or a related field.
• 3–5 years of experience handling audits and ISO documentation in a manufacturing environment.
• Strong knowledge of supplier management and quality standards (ISO 9001, 14001, 13485, ISO 22301).
• Familiarity with PFMEA, control plans, and GR&R.
• Experience with 8D and 5W problem‑solving methodologies.
• Excellent communication, presentation, and organizational skills.

Required skills

• Potential Failure Mode Effect Analysis (PFMEA)
• Control Plans
• Gage Repeatability & Reproducibility (GR&R)
• 8D problem‑solving methodology
• 5W problem‑solving methodology
• ISO 9001
• ISO 14001
• ISO 13485
• ISO 22301
• Supplier Management