Ingeniero Principal de Calidad
Core
Developing, implementing, and administering plant and departmental quality practices and procedures to ensure product compliance with QSR standards and specifications.
Role type
Principal Quality Engineer (Manufacturing)
Builds
Production quality systems and corrective action projects
Domain
Medical device manufacturing
Required skills
Quality system administration, customer complaint investigation, corrective action project implementation, internal/external audit coordination, regulatory process leadership, incoming inspection management, Kaizen project generation, accident/incident reporting, ISO13485 knowledge
Preferred skills
Advanced English proficiency, experience in maquiladora operations
Technologies
ISO13485, QSR systems
Responsibilities
Lead regulatory processes for manufacturing, calibration, validation, and environmental controls; supervise floor audits and TIQ release system; generate Kaizen projects and support OPEX; report on accidents and near-misses; ensure compliance with quality policies and training requirements.
Seniority
Senior, hands-on IC