Remote Risk Management Quality Engineer

Location: Nationwide
Compensation: To Be Discussed
Staff Reviewed: Thu, Sep 08, 2022
This job expires in: 5 days

Job Summary

A healthcare technology company has an open position for a Remote Risk Management Quality Engineer.

Core Responsibilities of this position include:

  • Reviewing Risk Management Matrix files
  • Assuring products meet regulatory requirements for risk management
  • Assisting with the creation of previously unidentified hazards

Qualifications Include:

  • 2+ years' experience with a BS or higher
  • Firm understanding of risk management requirements, hazard analysis, and risk scoring
  • Strong experience with statistical modelling, methodologies, and processes
  • Highly knowledgeable of 21 CFR 820, ISO 13485, ISO 14971, IEC 60601-1, IEC 62366, and IEC 62304 standards
  • 3+ years Quality Assurance, Fault Analysis, Engineering Technician, Post Market Surveillance, or related experience in a highly regulated industry
  • Experience working within a Quality Management System

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