Miguel Najarro

About Miguel Najarro

Thirty years of experience in Quality Engineering• Support new product development teams from initial phase to launch.• Lead cross functional teams for product improvement projects, including partnering with contract manufacturers and OEM suppliers to help them achieve high Quality products. • Lead / coordinate MRB, Calibration, EMI/EMC testing and Shock and Vibration Testing protocols/reports.• Provide validation support using a variety of tools: FMEA\'s, RA, Human Factors, IQ, OQ, PQ. • Validate Manufacturing Processes, Metrology / Test Equipment and Clean Rooms • Audit Quality Systems and Manufacturing Processes, Internal & at Supplier\'s sites • Perform DOE’s, MSA’s, Capability Analysis, implement SPC programs• Participate on DFSS / DFM programs. • Perform Failure / Root Cause Analysis, implement solutions to eliminate and minimize risks• Assure compliance cGMP, 21 CFR 820, ISO 13485, ISO 9001, CMDR, MDD, JPAL • Use Six Sigma methodologies. Strong knowledge on GD & T - ASME Y14•••09

Experience

1. Senior Quality Engineer - Supplier Management

   BD

   Oct 2014 — Present · San Jose, CA, US

   Responsible for Supplier Management. Supplier Qualification, Supplier Audits NPI and Improvements of existing products. Provide guidance in the areas of Process Validation, Design Control, Risk Management and Statistical Techniques.Ensure compliance to applicable internal and external requirements.Collaborate with R&D to help facilitate the successful launching of robust products.

Education

• City College of San Francisco

  Mechanical Engineering Technology / Computer Science

• Columbus University

  Mechanical / Quality Engineering

• UCSC Silicon Valley Extension

  Risk Management and Design Control for Medical Devices

  2014

• University of Wisconsin-Milwaukee

  Mechanical / Quality Engineering

Skills

• Quality Assurance
• Process Capability
• Biotechnology
• 5s
• Calibration
• Lean Manufacturing
• Design Control
• Continuous Improvement
• 21 Cfr
• Statistics
• Validation
• Minitab
• Medical Devices
• Spc
• Capa
• Iso 9000
• Testing
• Process Validation
• Fmea
• Qsr
• Cgmp
• Supplier Quality
• Iso 14971
• Corrective and Preventive Action (Capa)
• Design of Experiments
• Iso 13485
• Change Control
• 21 Cfr Part 11
• Root Cause Analysis
• Dmaic
• Doe
• Iso
• Sop
• Fda
• Quality System
• Quality Systems
• V&V
• Quality Control
• Gmp
• Six Sigma Green Belt Certification