Sunrise Medical Tecnologías, S.A. de C.V.

Quality Engineer

Sunrise Medical Tecnologías, S.A. de C.V.

Tijuana, Baja California

Septiembre 15 2026

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Correo de contacto

*****@sunmed.com

Giro

Maquiladora (Export.)

Actividad principal

Manufactura de productos médicos, sillas de ruedas y accesorios.

Número de empleados

650

Sitio Web corporativo

Datos de sucursal

(664) 364 6309

Sin Calle No. 22260 El realito, Delegación Presa Este Tijuana, Baja California

Descripción y detalle de las actividades

POSITION SUMMARY:

  • Ensure compliance with quality systems (ISO 13485, FDA QSR) during production processes.
  • Apply engineering/technical skills, six sigma and/or lean manufacturing methodologies to make recommendations and carry out Quality improvements with the Design, Manufacturing and Quality of the products and services offered to customers.
  • Perform product validations, process validations and equipment qualifications to maintain FDA compliance as applicable.

MAIN RESPONSIBILITIES

  • Provide Quality review for product design changes.
  • Review Design History Files (DHF) for accuracy and compliance to internal and regulatory (FDA) requirements.
  • Evaluate and investigate customer complaints: Includes failure analysis and resolution through an electronic system.
  • Generate statistical reports on quality performance in the process and in the product: Review quality data trending to determine if action(s) need to take place.
  • Execute CAPA (Corrective and Preventive Action) tools as required, both internally and externally, to bring about the desired changes and continuous improvement
  • Represent Quality on various teams, including ISO and/or FDA Audits, providing data information as needed, including internal audits.

Experiencia y requisitos

REQUIRED SKILLS, KNOWLEDGE AND EXPERIENCE

  • Engineer ( Industrial, Mechanical ) minimum of five years of quality or related discipline and/or equivalent combination of education and related experience
  • Strong Communication Skills (both written and verbal) Spanish and advanced English (MIN 85%)
  • Knowledge of quality systems: ISO 13485, 21 CFR 820
  • Experience with Risk Assessment tools such as HARMs, FMEA, MRB, CAPA, required.
  • Knowledge of methodologies: Lean Manufacturing, APQP, FMEA, SPC
  • Strong working knowledge of computer database systems, Microsoft applications, PC, and various software programs required.
  • Strong aptitude for problem solving, root cause analyses, and an understanding of dynamic mechanical assemblies desired.
  • Capable to present data (presentations) to management teams and train co-workers as needed.
  • Must have ability to properly interpret Engineering drawings and clearly present that information to others.
  • Ability to travel to other facilities to support quality audits and/or issues may be required.

COMPETENCIES REQUIRED

  • Analytical Thinking - Confront a problem using a logical, systematic, and sequential approach
  • Results orientation - Focus on the desired end result of oneself or of the team. Establish challenging goals, focusing efforts on meeting or exceeding objectives.
  • Prevention and problem solving - Visualize the future anticipate the implications and consequences of situations. Take the appropriate measures to be prepared for possible emergencies.
  • Customer orientation- Worry about the satisfaction of external and internal customers.
  • Oral Communication – Expressing oneself clearly in conversations and interactions with others.
  • Written Communication – Expressing oneself clearly in business writing.
  • -Diagnostic Information Gathering – Identifying the information needed to clarify a situation, seeking that information from appropriate sources, and using skillful questioning to draw out the information.

Beneficios

  • Beneficios de acuerdo a la LFT
  • Seguro de gastos médicos
  • Uniforme
  • Servicios medicos en planta
  • Comedor

Número de vacantes 1

Área Calidad

Contrato Permanente

Modalidad Presencial

Turno Diurno

Jornada Tiempo Completo

Estudios Carrera con título profesional

Inglés Hablado: Avanzado, Escrito: Avanzado

Disponibilidad p. viajar No