Mexicali, Baja California- Beneficios Superiores a LFT
Correo de contacto
*****@masimo.com
Giro
Maquiladora (Export.)
Actividad principal
Ensamble de sensores para oximetros (productos médicos).
Número de empleados
4350
Sitio Web corporativo
Aviso de privacidad
Descripción y detalle de las actividades
• Provide escalation support for significant quality issues
• Ensure timely assessment and containment of quality event
• Partner with R&D to embed quality and manufacturability into new product designs
• Support design controls for development and sustaining changes
• Participate in design reviews with a strong focus on producibility and risk
• Ensure design changes are manufacturable, verifiable, and compliant
• Support verification & validation activities with production-representative builds
• Support risk management (DFMEA, use-related risk, production risk inputs)
• Investigate design-related production issues and quality escapes
• Translate production floor feedback into actionable R&D design improvements
• Ensure design documentation and traceability (DHF, requirements, V&V) are audit-ready
• Support audits and inspections related to design controls
• Participate in MRB activities, ensuring consistent, compliant, and risk-based disposition of nonconforming material
• Ensure sustained compliance with applicable regulations and standards, including ISO 13485, FDA 21 CFR 820 (QSR), EU MDR (as applicable), and relevant IEC standards (e.g., IEC 60601-1)
• Collaborating with Supplier Quality and Supply Chain leadership on supplier-related quality issues
Experiencia y requisitos
• A/BS Degree, or equivalent combination of education and experience in a technical discipline is required
• 3+ years of experience in Design Quality Engineering, Product Quality, or Manufacturing Quality within a regulated industry
• Must have working knowledge of quality systems and practices
• Must be able to provide guidance to functional teams on quality requirements
• Experience in Quality Systems per ISO 13485
• Ability to work in a Project Team Environment
• Direct experience supporting manufacturing of regulated medical products
• Strong working knowledge of CAPA, nonconformance management, change control, and root cause analysis
• Excellent verbal and written communication skills
• Excellent prioritizing, organizational, and interpersonal skills
• Excellent documentation skills including detail-oriented, record maintenance/ tracking and understanding of document traceability
Beneficios
Número de vacantes 3
Área Calidad
Contrato Permanente
Modalidad Presencial
Turno Diurno
Jornada Tiempo Completo
Horario
- Monday to friday 08:00-17:30 hrs
Estudios Carrera con título profesional
Inglés Hablado: Avanzado, Escrito: Avanzado
Disponibilidad p. viajar No