Quality Engineer - Medical Device Manufacturing

Quality Engineer Opp - Direct Hire with mid sized Medical Device company in Irvine

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A bit about us:

Work for a stable and growing Medical Device Manufacturer based in Orange County!

Why join us?

Growth potential!
Work with a great team...
Competitive Pay and Benefits

Job Details

The Quality Engineer supports new product development, lean implementation, process capability improvement, daily production support, project management, technical data interpretation/analysis, and quality system management.

Principal Activities
  • Conduct product appraisal/Source inspections as required.
  • Interface with customer site Customer Quality issues associated with procured parts to drive solutions, minimize customer impact, and eliminate issue/s.
  • Drive manufacturing process capability improvements through variation reduction, error-proofing, and implementation of statistical process control.
  • Provide leadership to other functional areas such as planning/purchasing on problem solving teams to drive root cause analysis and Corrective/Preventive Action (CAPA) plans.
  • Work with sourcing group on supplier selection.
  • Develop process flow charts/diagrams and Process Failure Mode Effects Analysis (PFMEA).
  • Use lean and six sigma tools to drive process and product variation reduction.
  • Conduct and participate in the internal and external quality system, process, and product audits.
  • Develops and establishes problem/process root cause and definitive corrective action plans necessary to reduce Supplier Scrap, Rework and Repair costs.
  • Supplier Quality Improvement Projects – Work with procurement team to understand issues (data/fact driven), formulate documented plans, execute, continuously report results to leadership.
  • Supply Chain Performance – Ability to manage/publish supplier performance metrics, develop projects to improve processes and incorporate automation into our day to day workflow.

  • Product Appraisal – Expert interpreting and conducting product inspections.
  • Experience: Minimum of 2 years of progressive experience in quality and manufacturing
  • Six sigma tools and methodology; green belt or black belt experience is a plus.
  • Lean manufacturing practices to improve product/process quality.
  • Excellent problem-solving skills aimed at identifying and correcting the root causes of problems
  • Demonstrated ability to create and implement statistically valid control plans and audit plans

Education: Bachelor of Science degree in technical field AND/OR extensive verifiable experience in lieu of degree.
ASQ Certified- Certified Quality Auditor/ Certified Quality Manager

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Job Details
Managed by Jobot Pro
Irvine, CA
Monrovia, CA
Job Type
$75,000 - $90,000