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Descripción y detalle de las actividadesThe 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 standardsBeneficios- 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**- Tiempo completo- Turno Matutino**Estudios** Carrera con título profesional**Inglés**Hablado: Avanzado, Escrito: Avanzado**Disponibilidad p. viajar** No