Position location will be in Hartland, WI, San Diego, CA, Daytona, FL or Chicago, ILMerge, an IBM company, is a leading provider of innovative enterprise imaging, interoperability and clinical solutions that seek to advance healthcare. Merge’s enterprise and cloud-based technologies for image intensive specialties provide access to any image, anywhere, any time. Merge also provides intelligent solutions and software for clinical trials. Visit merge.com and follow us @MergeHealthcare.Working under moderate supervision the Recall Coordinator is responsible for coordinating product recall (corrections, removals, field safety corrective actions) activities to closure in a timely manner and for reporting to external stakeholders and authorities in compliance with international regulatory and quality requirements and standards. This role works closely with cross-functional teams to perform all aspects of investigation, documentation, customer notifications, regulatory reporting, effectiveness tracking, and closure of recalls. The Recall Coordinator prepares metrics and presents regular internal status reports on recall activities. The Recall Coordinator is a specific contributor to recall related process improvements and a general contributor to other Quality Management System (QMS) process improvements and execution. The Recall Coordinator prepares and provides training to the organization as required. Essential Job Duties
Facilitate and coordinate all aspects of performing international recall activities in a timely manner
Create regulatory recall reports, write and/or review field advisory notifications
Follow up on all aspects of recalls on a regular basis and report on status and trends
Prepare and deliver training material and seminars for recalls and other QMS topics
Comply with all corporate policies, processes and procedures
Contribute to QMS process improvement and execution as needed
Pursue a program of self-development through the use of selected reading, seminars, and participation in continuing education.
Identify and communicate possible improvements in the work process for customers and peers.
Utilizes excellent communication skills to prepare technical written and verbal communications to stakeholders, regulatory affairs, and customers.
Minimum one year of experience with a Quality Management Systems role in the healthcare industry
Experience in a quality role in a regulatory compliant medical device or life sciences organization
Working knowledge of compliant regulations and standards such as FDA QSR, ISO 13485, MDD 93/42/EEC, CMDCAS
Familiar with database entries and queries