Descripción y detalle de las actividades
The Quality Engineer III will lead complex quality initiatives, support regulatory compliance, and drive continuous improvement efforts in a fast-paced maquiladora environment. This role is ideal for a seasoned quality professional with strong problem-solving skills and deep knowledge of medical device regulations.
**Key Responsibilities**:
- Lead and support investigations for nonconformances, CAPAs, and customer complaints.
- Perform risk analysis, root cause analysis, and validation activities.
- Develop and improve quality systems in compliance with ISO 13485, FDA 21 CFR Part 820, and applicable regulatory requirements.
- Collaborate with cross-functional teams in manufacturing, engineering, and regulatory affairs.
- Conduct internal and supplier audits.
- Mentor and provide technical guidance to junior quality engineers.
- Drive continuous improvement projects and use of quality tools (Six Sigma, Lean, SPC, etc.).
Experiência y requisitos
Bachelor’s Degree in Engineering or related field.




Minimum 5 years of experience in Quality Engineering, preferably in the medical device industry.
Solid knowledge of ISO 13485, FDA QSR, and other applicable regulations.
Strong analytical, documentation, and communication skills.
Experience with CAPA systems, validation protocols, and statistical tools.
English proficiency required (written and spoken).
CQE certification or Six Sigma Green/Black Belt preferred.
Beneficios
- Beneficios de acuerdo a la LFT
- Seguro de vida
- Fondo de ahorro
- Seguro de gastos médicos
- Transporte
- Servicios medicos en planta
- Comedor
**Número de vacantes** 1
**Área** Calidad
**Contrato** Permanente
**Modalidad** Presencial
**Turno** Diurno
**Jornada** Tiempo Completo
**Horario**
- Tiempo completo
**Estudios** Carrera con título cualificado
**Inglés**Hablado: Avanzado, Escrito: Avanzado
**Disponibilidad p. viajar** No

📌 Quality Engineer Iii - Medical Device Manufacturing (Tijuana)
🏢 Importante Empresa Del Sector
📍 Tijuana