Accomplished, accountable quality professional with over 10 years of experience in the Food and Drug Administration & Health Canada regulated Medical Device industries offering Configuration Management and Product Lifecycle Management solutions. Strong analytical planner and problem solver who readily adapts to change, works well independently and with a team, and strives to exceed expectations. Able to understand user requirements, uncover unrealized requirements and business issues. Disciplined, well-organized investigator in Root Cause Analysis and identification of Corrective & Preventive Actions. Successfully manage multiple priorities and meet tight deadlines without compromising quality.Skills:Active Listening; Change Management; Continuous Improvement; Coordination; Cornerstone OnDemand; Corrective Action and Preventive Action; Critical Thinking; Cross-Functional Teamwork; Customer Service; Data Entry; Data Integrity; Docu-Proof; DocuSign; DocuWare; Driving Results; Emergency Preparedness; cGMP; Gap Analysis; Hewlett-Packard Application Lifecycle Management (HP ALM); Integration; Metrics; Microsoft Office; Microsoft Visio; Presentation; Process Improvement; Product Lifecycle Management; Project Management; Quality Collaboration by Design (QCBD); Quality Methods; Root Cause Investigation; SharePoint; Siemens Teamcenter Unified (TcU); Social Media; Standards, Codes, Regulations; Standards Compliance; Strategic Planning; Team Building; TrackWise8 – Account Request Management; TrackWise8 – Change Control Management (CCM); TrackWise8 – Exception Management; TrackWise8 – NCR CA/PA; Training / Education; Writing
Listed skills include Software Documentation, Access, Outlook, Microsoft Office, and 47 others.