Compliance Engineer

Santa Clara, CA 95054

Employment Type: Contract Category: Quality Engineer Job Number: 8353


  • B.S. in Engineering (Mechanical, Electrical, Industrial)
  • 5+ years of experience product compliance
  • SAP, Sharepoint, and MS Office Suite
  • Experience with lasers a plus
  • Experienced with quality engineering or a quality management role
  • 8D, CAPA, and FMEA’s
  • Experience with manufacturing environment


  • Review design data, identifying and resolving product and engineering design issues
  • Organize compliance program by preparing test plans, cost estimates, and required resources including test laboratories and equipment.
  • Maintain FDA/EMC/EMI/Safety test protocols 
  • Utilize expertise in the area of global standards compliance to analyze and provide input to program/project teams in the form of specific actions, tasks and plans related to compliance with applicable standards
  • Proactively manage compliance to revisions in standards throughout the product lifecycle
  • Manage and supervise formal compliance test activities at National and International Recognized Test facilities
  • Compile and provide required document packages to the CDRH for initial product filing requirements and annual reports.
  • Help lead and/or participate in solving compliance or quality related issues for products through 8D and scientific method approach in problem solving
  • Understand and maintain RoHS, REACH, EU DoC, and ISO 9001

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