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

Quality Engineer
Sunrise Medical Tecnologías, S.A. de C.V.
Tijuana, Baja California
Septiembre 15 2026
Corporativo
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
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
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
