IBM Watson Health Imaging, Compliance Specialist (CAPA) - Merge in HARTLAND, Wisconsin

Working under moderate supervision the CAPA Specialist is responsible for tracking and facilitating the implementation of corrective actions, corrections, preventive actions, opportunities for improvement and supplier corrective actions in compliance with regulatory and quality requirements and standards.This role works closely with CAPA owners from cross-functional teams including Regulatory and Quality Assurance, Solutions Management, R&D, Customer Support, Professional Services, Product Quality Assurance, and Fulfillment to assist with all aspects of resolving CAPAs.The CAPA Specialist helps to prepare information, including regular status reports, for the CAPA Manager and the CAPA Review Board to ensure that CAPAs are monitored, trended, and driven to closure to meet quality objectives.The CAPA Specialist is a specific contributor to CAPA related process improvements and a general contributor to other Quality Management System process improvements and execution. The CAPA Specialist prepares and provides training to the organization as required.Essential Job Duties

  • Provide assistance to CAPA owners and sponsors to follow the CAPA process and devise, implement and document appropriate actions to correct and prevent process and product nonconformities.

  • Follow up all CAPAs on a regular basis (e.g., weekly) to determine if they are being addressed in a timely manner, and escalate if they are not.

  • Maintain CAPA monitoring and trending dashboards

  • Assist with preparing reports for CAPA Review board, Management Reviews, and dashboards

  • Assist with coordinating CAPA Review Board meetings and document their action items

  • Assist with CAPA process improvement initiatives

  • Prepare and deliver training material and seminars for CAPA 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.

  • Perform other duties as assigned by immediate supervisor or upper management.

  • Bachelors Degree in a scientific discipline

  • Minimum 2 years’ experience with managing CAPAs in a medical device company

  • Experience in a quality role in a facility compliant with FDA QSR, ISO 13485, MDD 93/42/EEC, CMDCAS regulations and standards

  • Excellent interpersonal, communication, and negotiation skills

  • Familiar with software devices and software development