Remote Risk Management Quality Engineer

Job is Expired
Location: Nationwide
Compensation: To Be Discussed
Staff Reviewed: Sat, Nov 05, 2022

Job Summary

A health technology company has a current position open for a Remote Risk Management Quality Engineer.

Individual must be able to fulfill the following responsibilities:

  • Review Risk Management Matrix files to identify if issues are properly represented
  • Assure products meet regulatory requirements for risk management, including FDA QSR, MDD, EU MDR, CMDR, ISO 13485, ISO 14971
  • Create and continually improve procedures and work instructions to ensure reliable, repeatable results

Required Skills:

  • 3+ years Quality Assurance, Fault Analysis, Engineering Technician, or Post Market Surveillance
  • 2+ years’ experience with a BS or higher
  • Highly knowledgeable of 21 CFR 820, ISO 13485, ISO 14971, IEC 60601-1, IEC 62366, and IEC 62304 standards
  • Strong experience with statistical modeling, methodologies, and processes, including the use of a variety of accepted methods
  • Firm understanding of risk management requirements, hazard analysis, and risk scoring
  • Experience working within a Quality Management System

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