Sr. Engineer Risk Mgmt

Job Summary This role will be the senior lead contributor within the organization that creates, 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. This individual will collaborate with clinical, design engineering, regulatory, labeling, and international partners to ensure that risk is appropriately mitigated, evaluated, disclosed, and monitored. 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. Job Description MAJOR RESPONSIBILITIES: Create and align global risk management processes to ensure that risks are being analyzed consistently. Evaluate the risks and act as an approver for the following processes: Change Controls, Failure Mode Effect Analysis (FMEA), Medical Device Reporting (MDR), Recalls, Health Hazard Evaluations (HHEs), and other major quality events. Effectively communicate risks to senior global management. Build effective relationships with quality and business partners. Lead cross-department collaboration with R&D, Manufacturing, and other sites on a global level to ensure all risks are adequately addressed with robust risk controls. Create and manage systems to analyze multiple streams of data to gauge the health of a quality or 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. Lead and ensure