Descripción y detalle de las actividades
The Quality Systems
**Key Responsibilities**:
- Maintain and improve the Quality Management System in compliance with applicable standards (e.g., ISO 9001, ISO 13485, IATF 16949, AS9100).
- Support the planning, execution, and follow-up of internal and external audits.
- Collaborate with cross-functional teams to investigate audit findings and ensure timely implementation of corrective and preventive actions.
- Manage controlled documents, procedures, forms, and records within the QMS.
- Assist in gap assessments, management reviews, and regulatory readiness efforts.
- Track and report on QMS KPIs and metrics.
- Support training efforts related to quality system processes and regulatory compliance.
Contribute to continuous improvement initiatives across the organization.
Experiência y requisitos
**Qualifications**:
**Education**:
- Bachelor’s Degree in Engineering, Quality, or a related technical field.
**Experience**:
- 1-5 years of experience in a quality or regulatory role in manufacturing or regulated industries.
- Formal training as ISO lead auditor (ISO 9001 or equivalent).
- Experience participating in at least one external audit by a customer, registrar,



or regulatory agency.
- Familiarity with industry standards (ISO 9001, ISO 13485, IATF 16949, AS9100) and general quality tools.
**Technical Skills**:
- Good understanding of QMS principles, document control, nonconformance/CAPA systems.
- Proficient in Microsoft Office and QMS software (e.g., MasterControl, Arena, or similar platforms).
- Strong organizational and written communication skills.
**Language**:
- Proficiency in English (written and verbal).
**Preferred**:
- Experience in electronics manufacturing or medical device industry.
- Familiarity with risk management tools (e.g., FMEA, 5 Whys, Fishbone).
Working knowledge of ISO 13485, FDA 21 CFR 820, or related standards
Beneficios
- Beneficios de acuerdo a la LFT
- servicios médicos en planta
**Número de vacantes** 1
**Área** Calidad
**Contrato** Permanente
**Modalidad** Presencial
**Turno** Diurno
**Jornada** Tiempo Completo
**Horario**
- Jornada completa
- Turno Matutino
**Estudios** Carrera con título profesional
**Inglés**Hablado: Avanzado, Escrito: Avanzado
**Disponibilidad p. viajar** No

📌 Quality Systems Engineer (Ar) (Tijuana)
🏢 Grupo TECMA
📍 Tijuana