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18148 Requisition #
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  Qualifications - Quality Engineer - Medical Device Focus
  • This position assures company compliance to all pertinent United States FDA, state, and international regulatory requirements which are applicable to the design, manufacture and distribution of medical and diagnostic devices.
  • Knowledge of international quality and product standards for electro-mechanical equipment (e.g. ISO14971, ISO13485, EN60601, IEC62304, etc.)
  • Excellent written and oral communication
  • Strong project management and organizational skills.
  • Excellent verbal and written communication skills.
  • Strong analytical and problem solving skills.
  • Good leadership, analytical, written and interpersonal skills
 
  Education/Experience - Quality Engineer - Medical Device Focus
 
  • BA/BS degree in engineering or life sciences
  • At least five years of progressive experience in domestic/international regulatory submissions, design control systems and/or regulatory compliance.
  • Experience with product registration requirements US, Canada, EU and other major international markets i.e. China, Australia, Brazil, Saudi Arabia, etc.
  • Experience in the preparation of 510(k) submissions
  • Experience with development and post market support of Class I and II Medical Devices

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Requisition #: 18148