[Remote] Risk Management Engineer
Note: The job is a remote job and is open to candidates in USA. 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
Skills
- 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
Benefits
- Health insurance
- Life and disability
- 401(k) contributions
- Paid time off
Company Overview
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