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 *****, 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 *****, FDA, and GMP**:
- Proven leadership experience
- Experience with **statistical analysis and validation processes**:
- Advanced English (required)
Sueldo: $2,****** - $2,****** al día
Beneficios:
- Caja de ahorro
- Estacionamiento de la empresa
- Protegido de gastos médicos mayores
- Servicio de comedor con descuento
- Vacaciones adicionales o permisos con goce de sueldo
- Vales de despensa
Experiência:
- ISO *****: 3 años (Obligatorio)
- Metrologia : 3 años (Obligatorio)
Idioma:
- Inglés (Obligatorio)
Lugar de trabajo: Empleo presencial

📌 Metrology Qe Lead (Tecate)
🏢 Arterex
📍 Tecate