Principal Supplier Quality Engineer

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Irvine, CA
$1 - $2
Job Type
Direct Hire
Jul 27, 2018
Job ID
Principal Supplier Quality Engineer

Global medical devices leader seeks a Principal Supplier Quality Engineer with a focus on developing key suppliers and contract manufacturers working on a new, innovative Class III medical device.  Anticipated travel is 25% both domestic and international.  The Supplier Quality Engineer will work cross-functionally  Quality, R&D, and Operations in a leadership role in the development, qualification, improvement, and management of suppliers.   

The Principal Supplier Quality Engineer will:
  • Lead part qualification and supplier qualification activities
  • Develop inspection methods and plans, test method validation, and component capability assessments supporting component specification development and the identification of critical features,
  • At key supplier sites, lead risk management activities, including the development and implementation of FMEAs, process control plans, and quality agreements 
  • Support suppliers in the development, approval and execution of process validation protocols and reports for critical processes
  • Perform quality systems and processes audits at supplier sites which provide materials, components, sub-assemblies, and services.
  • Analyze and support the resolution of complex manufacturing and compliance issues at supplier sites
  • Utilizing statistical techniques and six sigma tools analyze processes and drive continuous improvement activities
  • Collect and analyze quality metrics relating to supplier quality
  • Train, coach and mentor quality engineers as a subject matter expert in key technical areas
  • Communicate supplier quality risks to upper management identifying solutions to mitigate risks
  • Support process and system improvement projects as assigned by manager
  • Bachelor's degree in engineering, disciplines could include mechanical engineering, chemical engineering, manufacturing engineering, industrial engineering; advanced degree preferred
  • 8+ years in medical device manufacturing with a depth of experience the development of suppliers and contract manufacturing operations
  • Extensive experience in new process qualification, including IQ, OQ, PQ
  • Experience with Class III medical devices including working knowledge of process transfer, scale up and process design, manufacturing
  • Strong knowledge and understanding of FDA’s 21 CFR Part 820, ISO13485, ISO9001, and other International regulations
  • Demonstrated engineering experience in supplier quality, supplier development, new product development, or manufacturing engineering in medical device or other regulated industry
  • Thorough understanding of risk management principles and techniques
  • Experience with the use of statistical techniques, Six Sigma tools, and DMAIC problem solving techniques.
  • Strong problem solving and critical thinking skills.
  • Ability to effectively communicate across different levels of the organization
  • Ability to work independently without close supervision
  • Ability to manage competing priorities in a fast paced environment
  • Strong leadership and interpersonal skills, with the ability to negotiate and influence change.