Descripción y detalle de las actividades
We are seeking a Process Quality Engineer with experience in the medical device industry to ensure regulatory compliance and process stability within controlled manufacturing environments.
**Key Responsibilities**:
- Ensure compliance with applicable regulations such as ISO 13485 and FDA requirements.
- Maintain and continuously improve the Quality Management System (QMS) related to manufacturing processes.
- Develop and monitor process controls, including statistical analysis (SPC) and variation reduction initiatives.
- Lead investigations of process-related nonconformities and drive corrective and preventive actions (CAPA).
- Support process validations (IQ, OQ, PQ) and revalidations.
- Conduct risk analysis (PFMEA) and develop control plans.
- Provide support during internal, customer, and regulatory audits.
- Ensure compliance with cleanroom procedures and controlled environment standards.
Experiência y requisitos
**Qualifications**:
- Bachelor’s degree in Engineering (Industrial, Biomedical, Mechanical, or related field).




- Minimum 3 years of experience in process quality within the medical device industry.
- Experience working in cleanroom environments (ISO Class 7, 8, or equivalent).
- Strong knowledge of ISO 13485, and quality tools (PFMEA, 8D, SPC, MSA).
- Experience in process validation and technical documentation.
- **Advanced English (required).**:
- Strong analytical skills, attention to detail, and continuous improvement mindset.
Beneficios
- Beneficios de acuerdo a la LFT
- confiable de vida
- fondo de ahorro
- seguro de gastos médicos
- servicios médicos en planta
**Número de vacantes** 1
**Área** Calidad
**Contrato** Permanente
**Modalidad** Presencial
**Turno** Diurno
**Jornada** Tiempo Completo
**Horario**
- Tiempo completo
- Turno Matutino
- Lunes a viernes
**Estudios** Carrera con título profesional
**Inglés**Hablado: Avanzado, Escrito: Avanzado
**Disponibilidad p. viajar** No

📌 Quality Engineer (Ciudad Juárez)
🏢 Grupo TECMA
📍 Ciudad Juárez