Lead and execute validations and qualifications of manufacturing processes, ensuring compliance with quality standards and regulations such as ISO 13485 and 21 CFR 820.

Analyze production issues and scrap codes using troubleshooting methodologies, root cause analysis, and tools such as FMEA and CAPA.

Coordinate and participate in daily management meetings, gemba walks, and cross-functional projects to ensure continuity and continuous improvement of production processes.

Provide support for internal and external audits, as well as technical docu...