Supplier Quality Engineer

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Irvine, CA
$1 - $2
Job Type
Direct Hire
Bachelor of Science
Feb 27, 2018
Job ID
Supplier Quality Engineer - Medical Devices

Global medical devices leader seeks a Supplier Quality Engineer to lead internal and external audits of Class III medical devices.  The Supplier Quality Engineer will audit a wide range of quality subsystems at company and client sites with approximately 50% travel, typically 2-3 days per week.  Additionally the Supplier Quality Engineer will:
  • Create audit schedules and site audit agendas, working with internal teams.
  • Run audit adhering to scheduled time allocations.
  • Formalize and submit complete audit report, which would include audit observation, findings, recommendations
  • Work with supplier and internal customers, based on specific audit, to complete audit response form.  This would include investigation, implementation and control phase
  • Work with audit site team to reach appropriate root cause and corrective action.
  • Work collaboratively to generate metrics for overall auditing system and and to identify continuous improvement opportunities;
  • Lead supplier or internal quality projects such as designing and/or recommending systems, procedures, supplier and internal audit improvement projects, etc
  • Bachelor’s degree in engineering
  • 4+ years relevant experience in medical device or pharmaceutical industry
  • 2+ years experience in quality compliance auditing in medical devices
  • The ability to travel up to 50%
  • Quality certifications such as:  ASQ -CQA, CBA, AQA, RAB, CQE strongly preferred
  • Lead auditor certification preferred
  • Working knowledge of Microsoft Office Suite,.Microsoft Word, Excel, PowerPoint, Visio, etc.)
  • Strong working knowledge of Quality System regulation (QSR / FDA regulation), and ISO13485 standards
  • Design control and validation experience is a plus.