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 13485), 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 13485, 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 13485, FDA 21 CFR Part 820.
- Advanced English (required).
- Strong leadership, strategic thinking, and communication skills.
Ventajas
- 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

📌 Senior Quality Manager (Tijuana)
🏢 Reconocida empresa
📍 Tijuana