Mandi Yohman Email & Phone Number

Youngstown, OH, US

Amsterdam, Noord-Holland, NL

• Experienced in Ultrasound, Emergency Care, CT-AMI, Patient Monitoring, and Software products
• Complaint Investigation: Lead and manage the end-to-end process of handling medical device complaints, including thorough investigation, documentation, and analysis of complaints received from healthcare providers.
• Documentation: help the team maintain comprehensive records of complaint investigations, ensuring accuracy and compliance with regulatory documentation requirements and help assemble and lead trainings
• Trend Analysis: Analyze complaint data to identify trends and patterns, providing insights to improve product quality, design, and user experience
• Regulatory Reporting: help ensure timely and accurate reporting of adverse events to regulatory authorities, in compliance with applicable regulations.
• CAPA Implementation: Lead and support Corrective and Preventive Action (CAPA) activities related to post-market surveillance findings

Amsterdam, Noord-Holland, NL

• Investigate and resolve reportable/adverse event complaints
• Review analysis findings and service engineer notes while simultaneously collaborating with Vigilance Reporting Specialists to ensure timely reporting
• Partner cross functionally with Risk Management team to further identify if technical investigation is required along with identifying CAPAS, IIAs, or if any other reporting is necessary
• Complete and provide customer feedback letters when applicable
• Experienced with Hospital Patient Monitoring devices, Ultrasound devices, and Emergency Care devices

Amsterdam, Noord-Holland, NL

• Bedside Complaint Investigator that evaluates customer feedback, service records, and other sources and process accordingly
• Handle the receipt, processing, monitoring, and reporting of product defect complaints and determine risk assessment and hazards
• Investigate and document all activities to create a summary of a complaint with thorough evaluation
• Communicate with field service engineers, customers, call center representatives to gather further data
• QCM Subject Matter Expert that guides the team with answering processing questions, coding inquiries, and lead team trainings/new process implementations.
• Experience in compliance and auditing

• Helped with the running of multiple assisted-living facilities, adult day care centers, rehabilitation centers, and nursing homes
• 1000-hour internship with extensive detail in business relations and operations
• Experience in Case Management, Human Resources, Social Services, Minimum Data Set (MDS), and many other areas.
• Assisted in the overall hiring process and guiding candidates through paperwork, culture, expectations, and explaining day-to-day tasks
• Maintaining the planning, organizing, and supervising for the delivery of care to residential patients

Bachelor Of Science In Applied Science, Long Term Care/Business Administration

Nursing Science