Miguel Barajas
Quality Systems Manager
- Role
- Quality Systems Manager at Johnson & Johnson MedTech
- Location
- Santa Clara, CA, US
- LinkedIn followers
- 500 followers
About Miguel Barajas
Strategic, hands-on and detail-oriented quality lead with 15 years of experience building, managing and supervising effective Quality Management Systems compliant to ISO 13485, MDSAP, MDD, MDR and Rest of the World. Direct responsible for QMS sub processes such as Document Control, Calibration, CAPAs, Complaint Handling, NCRs, Internal/External Audits, Deviations, Management Review, Regulations and Standards Management, Process Validation, Incoming, Process & Final Inspections.12 years of experience as ISO 13485 Certified Lead Auditor and one year as ISO 14001 Internal Auditor attending more than 300 audit days with Notified Bodies, Regulatory Agencies and Customers
Experience
Quality Systems Manager
Jul 2024 — Present · Santa Clara, CA, US
Johnson & Johnson acquired Shockwave MedicalOverseeing QMS processes for Santa Clara, Minnesota and Costa Rica sites. Leading a group of Seven Quality Systems Specialists with responsibilities on Quality Management System and Environamental Management System subprocesses such as CAPA, Management Review, Quarterly KPI Reviews, Internal Audits, External Audits, Supplier Audits, Introduction of New Geographies and Product QMS Readiness, Regulation and Standards Management, and J&J Integration Activities.
Education
Universidad Autónoma de Baja California
Industrial Engineer, Quality Assurance
2005 — 2010
CETYS Universidad
Master of Business Administration (MBA), Senior Management
2013 — 2014
Skills
- Acciones Correctivas Y Preventivas
- Cross-Functional Team Leadership
- Root Cause Analysis
- Engineering
- Mejora De Procesos
- Mejora De Procesos De Negocio
- Sistema De Gestión De La Calidad
- Value Stream Mapping
- Lean Manufacturing
- Process Improvement
- Dmaic
- Manufacturing Engineering
- Electronics
- Medical Devices
- Validación
- Normas Iso
- Capa
- Fmea
- Mapa Del Flujo De Valor
- 5s
- Design of Experiments
- Manufacturing
- Six Sigma
- Análisis Modal De Fallos Y Efectos
- Administración De Alimentos Y Medicamentos
- Quality System
- Seis Sigma
- Iso 13485
- Productos Sanitarios
- Product Development
- Kaizen
- Electrónica
- Mejora Continua
- Análisis De Causa Raíz
- Continuous Improvement
- Control Estadístico De Procesos
- Spc
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.