Vacantes Co-Production

Quality Engineer / Ingeniero de Calidad


Description and Activities details

 - Monitoring and improvement of product quality.
- Defect, scrap and rework prevention.
- Continuous improvement of and adherence to Quality
Management System.
- Control, document, evaluate and disposition nonconforming
- Coordinate and monitor inspection activities.
- Supervise Quality Inspectors/Technicians and Document
Control personnel.
- Investigate, document and communicate customer complaints.
Notify QM if event is reportable per Medical Device Vigilance
Reporting standards and requirements
- Supplier Quality evaluation, monitoring, and improvement. -
- Review and approve validation activities.
- Support Design and Design Transfer activities as needed.
- Sterilizations for both ETO and Gamma Radiation in
accordance with the appropriate standards.
- Ensure adequacy and compliance of Environmentally
Controlled Areas.
- Provide support for and perform Document Control activities
as needed.
- Coordinate and perform Corrective Action and Preventive
Action activities as required.
- Internal auditing as required.
- Provide guidance on regulatory requirements.
- Perform and/or prepare installation, operational, and
performance qualification of equipment as needed.
- Provide product specifications and task specific instructions for
use by Assembly and Quality, personnel and when required
specifying the type of inspection or measuring equipment to be
- Conduct investigations for equipment failing calibration.
- Complete, review and approve fixture files as necessary
- Assist in maintaining traceability of products.
- All other duties as assigned.


Required Skills, Knowledge and Expertise

 ISO 9001 and 13485
Medical Device Directives and product — specific applicable standards
FDA Quality System Regulations
Canadian Medical Device Regulations
Eto sterilization
Gamma Sterilization
Quality Management Tools
Problem Solving
Root Cause Analysis
Supplier Performance
Project Management
Advanced Product Quality Planning (APQP)
Proficient in Microsoft Office Software suite
Able to train effectively
Able to prioritize and multi-task
Excellent customer service skills

Education, Certification

BS in Engineering, Biology or related science preferred
Quality and/or Regulatory experience in Medical Device manufacturing preferred,

Referencia :
Contrato :
Vacante(s) :
Experiencia :
1~2 Años
Nivel de Estudio :
Carrera Profesional
Lugar :
Tijuana, B.C. - Parque Industrial Thomas Alva Edison
Creado :
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  • Parque Industrial Thomas Alva Edison
    Blvd. Corredor Tijuana-Rosarito 2000, 15202
    Int. Mt8-10,11 Y12, Zona Cerril General
    C.P. 22330, Tijuana, Baja California, Mexico
  • +52(664)454-3330
  • This email address is being protected from spambots. You need JavaScript enabled to view it.