Merative

Manager

• Lead the designated complaint handling unit (DCHU) for Merge Healthcare’s medical imaging portfolio and manage the post market surveillance process
• Establish, implement, and maintain efficient and effective processes and supporting tools for complaint handling and post market surveillance
• Establish and maintain complete and accurate complaint files and other associated records
• Ensure prompt escalation of product safety concerns for investigation and event reporting to applicable regulatory authorities
• Define, collect, and analyze metrics and key performance indicators to monitor complaint handling effectiveness and provide inputs to Management Reviews
• Perform analysis of complaint trends to identify product quality and safety concerns and provide feedback to Product Management, Development, Customer Success, Quality Engineering, and Regulatory Affairs
• Collaborate with Regulatory Affairs to perform post market surveillance activities, including establishing post-market surveillance plans and reports and performing data analysis
• Ensure Post Market Surveillance feedback is provided to cross-functional teams
• Collaborate with cross-functional stakeholders to drive root cause analysis and implement corrective and preventive actions
• Escalate significant risks, issues, or concerns to executive leadership
• Participate in internal and external audits and inspections as necessary
• Provide oversight for development and improvement of quality programs, systems, processes, and procedures to ensure compliance with applicable regulation and standards
• Lead and mentor a high-performing team of direct reports, establish performance expectations, provide feedback, coaching, and recognition
• Ensure adequate resources are identified and allocated to achieve objectives and escalate issues to executive management

Senior Manager, Post-Market Surveillance

Solutions Engineer

• Demonstrate a mastery of Merge applications to provide advanced consultancy and highquality user training which promotes optimal product utilization.
• Ensure successful implementation, user acceptance testing, workflow design, clinical change management, super user/system administrator readiness, system configuration and training planning and delivery and adoption of the Merge Imaging solution.
• Work closely with Project Management, Technical Consulting, Sales and customer roles including system super users, administrators, physicians and other clinical roles.
• Assess current state workflow and customer goals to produce workflow recommendation and designs, configuration requirements, testing requirements, training plans and change management strategies
• Identify and manage physician/clinical champion stakeholders
• Provide input to project plans including testing plans, training plans and go-live plans
• Deliver training to super users and/or system administrators and support them in the successful support and training of end users
• Manage and support the customer during user acceptance testing to ensure configuration and customer expectations align before go-live
• Coordinate resourcing of additional Solution Consultant resources for end user and/or go-live support, where necessary
• Manage customer training completions and ensure accurate reporting and tracking
• Configure the Merge Imaging solution per customer requirements and agreed-upon workflows
• Support the customer during and post go-live with workflow or application questions and troubleshooting

Senior Manager, Post-Market Surveillance

Solutions Consultant, Radiology