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
Medline is the largest provider of medical-surgical products and supply chain solutions serving all points of care. It was founded in 1966, and is headquartered in Mundelein, Illinois, USA, with a workforce of 10001+ employees. Its website is http://www.medline.com/home.jsp.Company H1B Sponsorship
Medline has a track record of offering H1B sponsorships, with 74 in 2026, 340 in 2025, 142 in 2024, 141 in 2023, 143 in 2022, 137 in 2021, 113 in 2020. Please note that this does not guarantee sponsorship for this specific role.