Descripción y detalle de las actividades
- * lead and develop the quality team*, fostering a culture of excellence, accountability, and continuous improvement.
- * ensure achievement of quality kpis*, including product compliance, audit readiness, and customer satisfaction metrics.
- * oversee internal and external audits*, including regulatory inspections (fda, iso *), customer audits, and corporate assessments.
- * manage and monitor capas*, non-conformances, deviations, and change control processes to ensure timely resolution and effectiveness.
- * ensure robust validation protocols* for manufacturing processes, equipment, software systems, and cleaning procedures, in alignment with regulatory standards.
- * coordinate and deliver training programs* on quality systems, regulatory requirements, and best practices across departments.
- * drive continuous improvement initiatives*, including root cause analysis, risk management, and lean quality tools.
- * maintain and improve the quality management system (qms)* to ensure compliance with iso *, fda 21 cfr part 820, and applicable local regulations.
- * collaborate with cross-functional teams* (engineering, manufacturing, regulatory affairs, supply chain) to support product lifecycle and compliance.
- * monitor industry trends and regulatory changes*, ensuring the company remains proactive and compliant.
experiência y requisitos
- bachelor's degree in engineering or related field.
- minimum 8 years of experience in quality within the medical device sector.
- strong knowledge of iso *, fda 21 cfr part 820.
- advanced english (required).
- strong leadership, strategic thinking, and communication skills.
beneficios
- seguro dental (elegibilidad)
- plan de indexación
- seguro de gastos médicos
- seguro de vida
- fondo de ahorro
*número de vacantes* 1
*área* calidad
*contrato* permanente
*modalidad* presencial
*turno* diurno
*jornada* tiempo completo
*horario*
- tiempo completo
- flexible
- lunes a viernes
*estudios* carrera con título profesional
*inglés*hablado: avanzado, escrito: avanzado
*disponibilidad p.
viajar* si