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
- Support design transfer activities associated with sustaining changes, ensuring changes are correctly reflected in DMR/DHR documentation.
- Support design controls for development and sustaining changes
- Partner with R&D to embed quality and manufacturability into product designs
- Participate in design reviews with a strong focus on producibility and risk
- Ensure design changes are manufacturable, verifiable, and compliant
- Provide escalation support for significant quality issues
- Apply advanced statistical techniques and tools such as Design of Experiments (DOE), hypothesis testing (ANOVA), and process capability indices (Cpk/Ppk) to evaluate process stability and drive data-backed engineering decisions.
- Support verification & validation activities with production-representative builds
- Evaluate design changes for potential impact to existing risk files, and ensure risk management documentation is updated accordingly.
- 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 Assurance Quality Engineering, Product Quality, or Manufacturing Quality in medical device 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