Risk Management Engineer

Medline Industries, LP is a growing worldwide organization focused on enhancing risk controls for medical devices, cosmetics, and OTC drugs. The Risk Management Engineer will analyze quality data, manage risk-based trending systems, and collaborate with various teams to ensure compliance with regulatory standards.

Responsibilities:

• Analyze and normalize multiple streams of data to gauge the health of the risk management system
• Work with Subject Matter Experts (SMEs) to create a framework for Risk-based dashboards to be used for real-time decision-making and management reporting
• Provide detailed input to stakeholders on how to implement risk controls as well as create and implement controls
• Identify inefficiencies in Medline’s global quality management system
• Take action to address identified inefficiencies
• Develop timelines for all projects and ensure that deadlines and goals are being met
• Frequently update management and team on progress
• Proactively work with members of the division or project team to identify issues that might delay the project; make recommendations to improve time lines for project completion

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
• Masters of Science – Chemistry, Biology, Biotechnology, Chemical Manufacturing, or other related field
• Six Sigma certification