Quality Engineer Iii

hace 5 días

Tijuana, México Emprego MX A tiempo completo

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
- Seguro 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

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