Manager, Sustaining Quality Assurance Engineering

Masimo

Mexicali, Baja California

Febrero 27 2026

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
Participate in MRB activities, ensuring consistent, compliant, and risk-based disposition of nonconforming material
Own and oversee quality input to post-release design and process changes (ECOs, deviations, waivers, temporary changes)
Ensure thorough change impact assessments are performed to determine verification, validation, revalidation, and documentation requirements
Ensure appropriate risk controls, benefit-risk justifications, and verification activities are implemented and documented
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
Ensure supplier changes impacting released products are properly evaluated and approved
Support strategy for incoming inspection, supplier controls, and quality agreements
Act as a key quality leader partnering with Manufacturing Engineering, Design Engineering, Operations, Regulatory Affairs, Clinical, and Supply Chain
Lead, mentor, and develop a team of Sustaining Quality Engineers
Set clear priorities, goals, and performance expectations aligned with business and quality objectives
Ensure appropriate staffing, training, and skill development to support production needs.

Experiencia y requisitos

Bachelor's degree or equivalent combination of education and experience in a technical discipline is required.
English (Fluent)
5+ years of experience as a Quality Manager in the medical, aerospace, or automotive sector.
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 1

Área Calidad

Contrato Permanente

Modalidad Presencial

Turno Diurno

Jornada Tiempo Completo

Horario

Estudios Carrera con título profesional

Inglés Hablado: Avanzado, Escrito: Avanzado

Disponibilidad p. viajar Si