Edy Montero

About Edy Montero

Specialties: CAPA system, Sampling plan, Internal audits, Incoming quality inspection, continual improvement, validation, Risk Management (pFMEA, DFMEA, SFMEA, SRA, TUEA)

Experience

1. Staff Quality Assurance Engineer

   Beckman Coulter Diagnostics

   Aug 2018 — Present · Miami, TX, US

   Oversight QA risk management for the Miami, Florida product lines: hematology, urinalysis, and flow Cytometry.• Oversight on the implementation of the Beckman Coulter product safety risk management process for new product development projects, design changes, and facilitates risk management activities in compliance with Beckman Coulter procedures. • Responsible for teaching, coaching, and mentoring team members on risk management and approving all risk management deliverables (sFMEA, dFMEA, pFMEA, SRA, PLRA, etc.). • Act as a subject matter expert on risk management and provides support across the broader organization• Expertise in risk evaluation for post market issues for product safety and provides guidance on the completion of the risk documents• Approve all post launch risk assessments and facilitates the decision-making process among stake holders• Exercise independent judgment in evaluating complex processes, procedures and systems against written regulatory requirements and company procedures• Collaborate and resolve conflicts independently• Analysis and judgment and keep effective communication, teamwork, and negotiation skills while work with personnel at all levels of the organization.• Review Risk Management documents to ensure compliance with ISO 14971, 13485:2016, MDSAP and 21 CFR 820.• Lead auditor role; conduct internal audit on four different sites.(Colorado, Indianapolis, Hialeah, Miami)• Follow up to audit responses (Smart-Solve)• Conducting Root Cause analysis and Corrective/preventive actions• Handling Customer Complaints and field action escalation• Non-conforming review • Oversight Risk Management on new product launch• Oversight Risk Management on Design Change• Oversight Risk Management on Design Control

Education

• Universidad Autónoma de Santo Domingo

  Mechanical Engineer, Engineering

  1993 — 2000

Skills

• Fmea
• Cqa
• Quality Management
• Change Control
• Six Sigma
• Quality Auditing
• Quality System
• V&V
• Calibration
• Minitab
• Design Control
• Spc
• Iso
• Fda
• Tqm
• Cqe
• Manufacturing Operations
• 5s
• Continuous Improvement
• 21 Cfr
• Materials
• Validation
• Quality Assurance
• Quality Control
• Engineering
• Gmp
• Injection Molding
• Medical Devices
• Root Cause Analysis
• Capa
• Iso 9000
• Kaizen
• Value Stream Mapping
• Process Improvement
• Fda Gmp
• Process Engineering
• Ce Marking
• Design of Experiments
• Manufacturing
• Lean Manufacturing