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
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