Hill-Rom
Senior Director Global Quality Systems and Post Market Surveillance
Welch Allyn Jan 2012 - Sep 2015
Director Ra: Global High Risk Complaints and Capa
Welch Allyn Jan 2010 - Sep 2012
Senior Manager Global High Risk Complaint Logistics and Capa
Welch Allyn Jul 2007 - Dec 2009
Global Quality Systems, Senior Manager
Medtronic Oct 2006 - Jul 2007
Quality Systems Project Engineer
Education:
Purdue University 1995 - 2020
Bachelors, Bachelor of Science, Genetics, Microbiology
Skills:
Leadership Development Lotus Notes Data Analysis Process Simulation Capa Fda Iso 13485 Quality System Medical Devices Validation V&V Design Control Quality Assurance Continuous Improvement Process Improvement Gmp Quality Auditing 21 Cfr Part 11 Iso 14971 Dmaic Regulatory Affairs Regulatory Requirements Sop Iso Business Process Improvement Mdr Product Complaints Iso Standards Standard Operating Procedure U.s. Food and Drug Administration Corrective and Preventive Action Complaint Management Management Review Post Market Surveillance Recalls Adverse Events
John A. Melquist - Skaneateles NY, US Carol A. Williams - Liverpool NY, US Pearley Bhambri - Camillus NY, US Brian R. Ray - Camillus NY, US Craig D. Mullin - Memphis NY, US Richard W. Thomas - Syracuse NY, US
Assignee:
WELCH ALLYN, INC. - Skaneateles Falls NY
International Classification:
G06Q 10/00
US Classification:
705 728
Abstract:
A risk-based complaint management system is provided to effectively prioritize risks and streamline a complaint process. The risk-based complaint management system comprises a risk assessment database and a risk engine. The risk assessment database is provided to establish and maintain product-specific questions. The product-specific questions are associated to risk and severity levels of product risk assessment. The risk engine is configured to determine a risk level of a customer complaint based on responses to the product-specific questions with regards to the customer complaint.