Descripción y detalle de las actividades
**Key Responsibilities**:
- Lead root cause analysis and corrective/preventive actions (CAPA) for non-conformities and customer complaints.
- Support validation and qualification activities (IQ, OQ, PQ) for processes and equipment.
- Collaborate with cross-functional teams (Engineering, Manufacturing, Regulatory, etc.) to implement quality improvements.
- Conduct internal audits and support external audits (e.g., FDA, ISO, customers).
- Maintain and improve quality system documentation in compliance with medical device regulations.
- Analyze quality data and drive metrics for performance improvement.
- Provide support for risk management activities (FMEA, hazard analysis).
- Train and mentor junior quality team members.
Experiência y requisitos
- Bachelor’s degree in Engineering or related field.
- 5+ years of experience in quality engineering within a medical device manufacturing environment.
- Strong knowledge of ISO 13485, FDA 21 CFR Part 820, and other applicable regulations.
- Experience with CAPA, validation,



risk management, and root cause analysis.
- Proficiency in quality tools and methodologies (Six Sigma, Lean, SPC, etc.).
- Strong communication and problem-solving skills.
- English proficiency (spoken and written).
**Preferred**:
- Certified Quality Engineer (CQE) or similar certification.
- Experience with software tools for quality management systems (e.g., MasterControl, ETQ).
Beneficios
- Beneficios de acuerdo a la LFT
- Seguro de vida
- Fondo de ahorro
- Protegido de gastos médicos
- Transporte
- Plan de indexación
- Servicios medicos en planta
- Comedor
**Número de vacantes** 1
**Área** Calidad
**Contrato** Permanente
**Modalidad** Presencial
**Turno** Nocturno
**Jornada** Tiempo Completo
**Horario**
- Tiempo completo
**Estudios** Carrera con título profesional
**Inglés**Hablado: Avanzado, Escrito: Avanzado
**Disponibilidad p. viajar** No

📌 Quality Engineer Iii (Tijuana)
🏢 Empresa reconocida
📍 Tijuana