Descripción y detalle de las actividades
**RESPONSABILITIES**
- Expertise regarding current regulatory requirements and international standards.
- Performs regulatory and system internal audits to ensure systems are documented, procedures are followed and are adequate according to ISO9001:2015, ISO13485:2016 and 21 CFR Part 820.
- Ensure that all the Quality System Procedures are in compliance with the international standards and regulatory requirements.
- Participate in project development teams and review plans, reports, risk management and design reviews associated with product and process projects.
- Prepares internal audit plans and identifies the roles and responsibilities of audit team members.
- Ensure that internal audit plan is followed and completed according to the approved annual audit plan.
- Participate as Internal auditor leader to develop the rest of the internal auditor’s team
- Follow up corrective / preventive actions generated by internal and external audits to ensure that are documented and completed properly.
- Prepares audit reports by collecting, analyzing, and summarizing operating information and trends and report audit results.
- Responsible for the CAPA system,



ensuring that all the corrective / preventive actions are documented and closed according to the implemented procedures.
- Responsible to complete the effectiveness verification for all the CAPAs generated
- Perform and/or lead failure investigations for CAPA and/or audit findings investigations.
- Support during internal and external audits
Experiência y requisitos
**JOB REQUIREMENTS**
- Bachelor’s Degree in Industrial, Electrical, Systems or Mechanical Engineering.
- 5+ years of experience in manufacturing environments
- Experience participating in Quality Audits
- Knowledge of statistical techniques, acceptance sampling, and SPC.
**QUALIFICATIONS AND SKILLS**
- Knowledge of Quality Systems, ISO13485:2016 Standard
- FDA Regulations
Beneficios
- Beneficios de acuerdo a la LFT
- Aguinaldo superior a Ley
- Dias por enfermedad
- Seguro de Gastos Medicos Mayores
- Dias de descanso superior a Ley
**Número de vacantes** 1
**Área** Calidad
**Contrato** Permanente
**Modalidad** Presencial
**Turno** Diurno
**Jornada** Tiempo Completo
**Horario**
- Jornada completa
- Turno Matutino
- Tuno de 10 horas
- Lunes a viernes
**Estudios** Carrera con título profesional
**Inglés**Hablado: Avanzado, Escrito: Avanzado
**Disponibilidad p. viajar** No

📌 Quality System Engineer (Tijuana)
🏢 Rogers Foam Tijuana
📍 Tijuana