Risk Management Engineer

Job Summary

Key contributor within the organization that monitors, maintains, and enhances risk controls by analyzing quality data and major quality events to ensure Medline is properly controlling risks on a global level for medical devices, cosmetics, and OTC drugs. Responsible for managing an automated risk-based trending system that will help the organization foresee risks as well as objectively prove that risk controls are effective. Provide expertise to the organization including education, technical support, issue resolution, and integration of new or enhanced risk controls to be compliant with EU MDR along with satisfying FDA, ISO 13485, and ISO 14971 risk management related processes throughout the product life cycle. Collaborate with Medline’s R&D team during design and development, manufacturing teams to implement appropriate risk controls, post-market surveillance teams to determine if new risks have arisen, and Regulatory Affairs to support FDA inspections.

Job Description

• 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.

Minimum Job Requirements

• Education: Bachelor of Science Degree in Biology, Chemistry, Engineering or Statistics-based degree.
• Experience: 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.
• Skills: Experience with Data visualization tools/business intelligence tools such as Tableau, Power BI, or Qlik. Experience leading multiple, complex projects.
• Knowledge: 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.

Prior to Job Requirements

• Education: Masters of Science – Chemistry, Biology, Biotechnology, Chemical Manufacturing, or other related field.
• Certification/Licensure: Six Sigma certification.

Pay

The Anticipated Salary Range For This Position $79,000.00 - $119,000.00 Annual The actual salary will vary based on applicant’s location, education, experience, skills, and abilities.

Benefits

• Health insurance
• Life and disability
• 401(k) contributions
• Paid time off