We are seeking a Quality Engineering Lead with strong expertise in metrology to lead quality systems and ensure compliance within a medical device manufacturing environment.

This role will be responsible for driving measurement excellence, supporting validation activities, and ensuring compliance with regulatory standards such as FDA and ISO.

Key Responsibilities
- Lead and mentor the Quality Engineering team:
- Oversee and improve metrology systems (CMM, vision systems, calibration programs)
- Ensure compliance with FDA regulations, ISO 13485, and GMP requirements:
- Support and lead validation activities (IQ, OQ, PQ)
- Drive process capability analysis (Cp, Cpk) and continuous improvement initiatives
- Lead root cause investigations and CAPA implementation
- Develop and maintain inspection methods, control plans, and quality documentation:
- Partner with Manufacturing, Engineering, and Operations to ensure product quality and compliance
- Support internal and external audits





Qualifications
- Bachelor’s degree in Engineering or related field
- Extensive experience in metrology (CMM, GD&T;, calibration systems)
- Experience in medical device or regulated industry:
- Strong knowledge of ISO 13485, FDA, and GMP:
- Proven leadership experience
- Experience with statistical analysis and validation processes:
- Advanced English (required)

Sueldo: $2,000.00 - $2,300.00 al día

Ventajas:
- Caja de ahorro
- Estacionamiento de la empresa
- Seguro de gastos médicos mayores
- Servicio de comedor con descuento
- Vacaciones adicionales o permisos con goce de sueldo
- Vales de despensa

Experiência:
- ISO 13485: 3 años (Obligatorio)
- Metrologia : 3 años (Obligatorio)

Idioma:
- Inglés (Obligatorio)

Lugar de trabajo: Empleo presencial

📌 Metrology Qe Lead (Tecate)
🏢 Arterex
📍 Tecate