Risk Management Engineer
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
• 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