Senior Quality Improvement Engineer

About the role

The Senior Quality Improvement Engineer is responsible for implementing and monitoring the quality system, ensuring compliance with internal and external audits, and driving continuous improvement across the manufacturing site.

Key responsibilities

• Implement and monitor the Quality System and ensure readiness for audits such as MDSAP, LRQA, BSI Micro, and Kazakhstan.
• Lead CAPA investigations, manage NCRs, complaints, and quality feedback.
• Execute and approve production and process changes, including engineering studies, validation protocols, and software validation.
• Perform risk assessments, HHE, and manage calibration investigations.
• Monitor quality KPIs, develop actions to improve them, and support the site’s quality culture.
• Prepare rework protocols, manage lot blocking, and ensure containment of non‑conforming material.
• Support metrology activities and ensure compliance with specifications and regulations.

Required profile

• Minimum five years of experience in Quality Engineering.
• Bachelor’s degree in engineering, science, or a related field (or equivalent experience).

Required skills

• Knowledge of QSR and ISO 13485 quality standards.
• Proficiency in statistical techniques and problem‑solving methods.
• Fluent oral and written communication in English and Spanish.
• Advanced computer skills: Excel, Word, PowerPoint.