• Develop quality testing methods, documentation, and test procedures.
• Implement and maintain quality standards in accordance with ISO 13485.
• Manage quality system metrics such as Customer Complaints (CCs), Non-Conforming Material Reports (NCMRs), and Corrective and Preventive Actions (CAPA).
• Lead and support project and sustaining activities, including test method validations, first article inspections (FAI), product inspections, and material releases.
• Implement, review, and support Engineering Change Orders (ECOs).
• Establish detailed quality standards and ensure compliance with organizational quality objectives.
• Conduct and support internal, external, and customer audits.
• Define and monitor quality metrics for manufacturing processes.
• Supervise and manage workload of quality technicians and inspectors, as applicable.
• Perform inspections of materials and products based on specifications and requirements.
• Conduct root cause analysis using industry-standard methodologies.
• Prepare reports on quality issues and corrective actions.
• Collaborate with cross-functional teams to improve product quality and customer satisfaction.
• Develop team structures and support the growth and development of team members.

• Bachelor’s degree in Industrial Engineering, Quality Engineering, or related field.
• Minimum 3 years of experience in QMS within the medical device industry.
• Strong knowledge of:

• ISO 13485
• CAPA systems
• Internal and external audits
• Root cause analysis
• Quality system documentation

Advanced English (required).

• Beneficios de acuerdo a la LFT
• Seguro de vida
• Transporte
• Uniforme
• Utilidades garantizadas
• Caja de ahorro
• Servicios medicos en planta
• Comedor
• seguro de vida
• caja de ahorro
• comedor
• transporte
• uniforme
• gimnasio
• seguro de gastos médicos