Descripción y detalle de las actividades
- Support the development, implementation, and maintenance of the Quality Management System (QMS) in compliance with ISO 13485 and FDA 21 CFR Part 820.
- Assist in the investigation and documentation of non-conformances (NCRs), root cause analysis, and implementation of corrective and preventive actions (CAPAs).
- Participate in internal audits and help prepare documentation for regulatory and customer audits.
- Collaborate with Engineering, Manufacturing, and Regulatory teams to ensure quality requirements are met during product development and manufacturing.
- Review and approve Device History Records (DHRs), incoming inspection results, and production batch documentation.
- Develop and validate measurement and inspection techniques for in-process and finished medical device products, ensuring accuracy, repeatability, and compliance with product specifications and regulatory requirements
- Support production line troubleshooting by identifying quality issues and assisting Manufacturi
Experiência y requisitos
- Bachelor’s degree in Biomedical, Industrial, Mechanical or a related technical field.
- 1-2 years of experience in a regulated industry (preferably medical devices, pharmaceuticals,



or similar manufacturing environments).
- Knowledge of quality and regulatory standards, such as ISO 13485 and FDA 21 CFR Part 820.
- Familiarity with inspection tools such as calipers, micrometers, optical comparators, and other precision measurement equipment.
- Ability to read and interpret technical drawings, specifications, and inspection instructions.
- Understanding of validation principles (IQ, OQ, PQ) and quality assurance methodologies.
- Exposure to root cause analysis tools and corrective/preventive action (CAPA) processes.
- Proficiency in Microsoft Office (Excel, Word, Outlook); experience with ERP or QMS systems is a plus.
- Strong communication and teamwork skills, with a hands-on, detail-oriented approach.
Beneficios
- Beneficios de acuerdo a la LFT
- seguro de vida
- fondo de ahorro
- seguro de gastos médicos
**Número de vacantes** 1
**Área** Calidad
**Contrato** Permanente
**Modalidad** Presencial
**Turno** Diurno
**Jornada** Jornada completa
**Horario**
- Tiempo completo
**Estudios** Carrera con título profesional
**Inglés**Hablado: Avanzado, Escrito: Avanzado
**Disponibilidad p. viajar** No

📌 Quality Engineer - Reforma Ct (Tijuana)
🏢 Grupo TECMA
📍 Tijuana