Supplier Quality Manager

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Location
Irvine, CA
Salary
$1 - $2
Job Type
Direct Hire
Degree
Bachelor of Science
Date
Dec 07, 2018
Job ID
2644774
Global medical devices leader seeks a Supplier Quality Manager to lead a supplier quality team in the development of new Class III medical devices.  The Supplier Quality Engineer lead supplier quality initiatives and qualifications as well as provide mentoring and oversight of a supplier quality team.  Travel is expected to be around 25%, both domestic and international.   Additionally the Supplier Quality Manager will:
 
  • Manage investigation nonconformance issues identified for device components. 
  • Ensure compliance of supplier files 
  • Identify supplier quality engineering resource requirements and manage resources to providing quality coverage for the new product development programs
  • Lead continuous improvement initiatives, including quality system and supplier qualification procedures 
  • Manage supplier quality team 
Requirements:
  • Bachelor's degree in engineering required; advanced degree preferred
  • 8+ years relevant experience in medical devices, preferably Class III
  • A background in medical device product development
  • 5+ years leadership experience
  • Strong management and leadership skills to ensure management, growth and development of personnel.
  • Previous supervisory experience 
  • Strong statistical and analytical skills
  • A track record of accomplishment managing multiple competing projects or programs
  • The ability to travel up to 25% both domestic and international
  • 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.