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Risk Management Engineer

100% Remote Full-time Open now

Job Description:

  • Key contributor within the organization that monitors, maintains, and enhances risk controls by analyzing quality data and major quality events
  • Responsible for managing an automated risk-based trending system
  • Provide expertise to the organization including education, technical support, issue resolution, and integration of new or enhanced risk controls
  • Collaborate with Medline’s R&D team during design and development
  • Work with Subject Matter Experts (SMEs) to create a framework for Risk-based dashboards
  • Analyze and normalize multiple streams of data to gauge the health of the risk management system
  • Proactively work with members of the division or project team to identify issues that might delay the project
  • Develop timelines for all projects and ensure that deadlines and goals are being met
  • Take action to address identified inefficiencies in Medline’s global quality management system.

Requirements:

  • Bachelor of Science Degree in Biology, Chemistry, Engineering or Statistics-based degree
  • At least 2 years of QA/QE experience in a cGMP Device or environment
  • Complete device life cycle experience related to design, production, use of a device, and ISO 14971
  • Experience with Data visualization tools/business intelligence tools such as Tableau, Power BI, or Qlik
  • Experience leading multiple, complex projects
  • Strong ability to manage multiple priorities
  • Self-starter attitude
  • Good oral and writing skills
  • Ability to work independently and as a team in an efficient manner.

Benefits:

  • Health insurance
  • Life and disability insurance
  • 401(k) contributions
  • Paid time off
  • Employee Assistance Program
  • Employee Resource Groups
  • Employee Service Corp

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