Justin Elerath

About Justin Elerath

I am a dedicated, multifaceted Quality and Manufacturing Engineering Management Professional, with extensive experience in leading production/process engineer, R&D, project direction, quality assurance, process improvement, budget control and operations management.

Experience

1. Sr Qa Reliability Manager

   Werfen

   Jun 2022 — Present · Bedford, MA, US

   Lead a team of 25 Quality Assurance professionals in the investigation of complaints and assessment of post-market Risk Assessment according to ISO14971. Lead cross functional team to assess the potential harm of malfunctions observed in the field.• Maintain a staffing plan to support the current workload. Assessing projected complaint volume based on sales and historical complaint rates by product line.• Escalate field issues for CAPA/recall and regulatory reporting.• Use regulations/guidances/standards to develop process improvements that address throughput while improving compliance profile.

Education

• University of Arizona

  BS, Mechanical Engineering

  1995 — 1999

• University of Southern California

  MS, Mechanical Engineering

  2007 — 2011

Skills

• Solidworks
• Cost Avoidance
• Equipment Qualification
• Iso 13485
• Lean Manufacturing
• Robotics
• Gd&T
• Quality System
• Corrective and Preventive Action (Capa)
• Manufacturing Engineering
• U.s. Food and Drug Administration (Fda)
• Complaint Investigations
• Design of Experiments
• Manufacturing
• Team Leadership
• 21 Cfr 803
• Design for Manufacturing
• Fmea
• R & D
• Medical Devices
• Capa
• Design Control
• Cost Reduction
• 21 Cfr 820
• Root Cause Analysis
• Manufacturing Engineering Management
• Capas
• Cross-Functional Team Leadership
• Performance Management
• Continuous Improvement
• Mechanical Engineering
• Research and Development (R
• Spc
• Automation
• Fda
• 21 Cfr 806
• R