Sean Blazo personal email
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Specialties: Logical Problem Solving, Process Mapping, Effective Communication, Data Trending, Data Analysis, CAPA Project Management and Facilitation, Root Cause Investigation, All Phases of CAPA Process, 8D Problem Solving Process, Microsoft Excel, Project Leadership, FDA 21 CFR 820
Sean Blazo Llc
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OwnerSean Blazo Llc 2015 - PresentProvider of Professional Quality Systems Consulting Services
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Pqe ConsultantOxford International 2015 - 2016Cleveland, Oh▪ Reviewed and completed nonconformance records including nonconformance investigations within SAP software▪ Led analysis for the nonconforming product quality notifications and participating in material review board (MRB) activities▪ Ensured Good Manufacturing Practice (GMP) compliance in manufacturing areas▪ Conducted Defective on Arrival (DEFOA) investigations and implementation of related Corrective Action and Preventive Action (CAPAs)▪ Conducted CAPA Requests for nonconformance trends -
Capa Sme ConsultantMaetrics 2013 - 2015Monument, Co▪ Prepared, revised, and conducted classroom training on root cause investigations, CAPA Process, and CAPA modules (EtQ and CATSWeb) ▪ Remediated CAPAs with CAPA Owners and cross-functional teams▪ Managed and facilitated all phases of the CAPA process▪ Led root cause CAPA investigations▪ Provided and implemented feedback on CAPA procedures and systems▪ Worked with multiple sites to coordinate CAPA activities -
Capa EngineerTerumo Cardiovascular Systems 2011 - 2012Ann Arbor, Mi▪ Managed, led and facilitated all phases of the CAPA process▪ Led 8D Root Cause Investigations with cross-functional teams▪ Coordinated various functions across multiple departments to initiate and drive progress of product, process, and consent decree workstream CAPAs▪ Provided CAPA representation throughout other functions of organization such as 8D Team Meetings▪ Owned CAPA projects involving multiple departments and working with CAPA workstream owners to close and combine open product CAPAs into systemic, process-oriented workstream CAPAs▪ Updated and prepared all CAPA documentation to comply with FDA 21 CFR Part 820 Regulations▪ Created and continuously improved CAPA metrics to target measurable objective and critical data to improve health of the CAPA system -
Associate Capa SpecialistStryker Instruments 2009 - 2010▪ Created system of nonconformance data trending, analysis and communication through initiating and leading the plant wide, cross-divisional "NCMB 2.0" (NonConformance Monitoring Board) project. ▪ Prepared documentation for the NCMB 2.0 project as an example of the division exceeding a newly enforced FDA requirement▪ Assisted in providing feedback for development of TrackWise CAPA Module▪ Initiated and conducted product health risk assessments of nonconformances in the field and in the manufacturing area▪ Critiqued CAPA documentation for accuracy and compliance to FDA standards while playing a role in preparing for all remediation efforts of internal, FDA, ISO, and TUV Audits▪ Initiated and aligned use of quality data trending and analysis across the plant resulting in a faster response time to safety related nonconformances -
Capa CoordinatorStryker Instruments 2008 - 2009▪ Expanded position's responsibilities to provide assistance to health and business risk assessments & CAPA by completing documentation, filling gaps in communication throughout CAPA processes, and providing feedback on procedures ▪ Integrated statistical methods with non-conformance trends in order to identify adverse trends of non-conforming product and processes▪ Learned statistical methods and applications on Minitab and advanced functions in Excel▪ Implemented over a dozen new trending metrics focused on improving product quality through presentation at NCMB meetings
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Group Coordinator/WebmasterObm Network 2008 - 2010
Sean Blazo Skills
Sean Blazo Education Details
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Behavior Analysis -
Applied Behavior Analysis
Frequently Asked Questions about Sean Blazo
What company does Sean Blazo work for?
Sean Blazo works for Sean Blazo Llc
What is Sean Blazo's role at the current company?
Sean Blazo's current role is Owner at Sean Blazo LLC.
What is Sean Blazo's email address?
Sean Blazo's email address is se****@****ail.com
What schools did Sean Blazo attend?
Sean Blazo attended Western Michigan University, Western Michigan University.
What are some of Sean Blazo's interests?
Sean Blazo has interest in Organizational Structuring, Organization Behavior Management, Continuous Improvement, Process Improvement, Statistics, Organizational Development, Performance Management, Statistical Process Controls.
What skills is Sean Blazo known for?
Sean Blazo has skills like Capa, Medical Devices, Fda, Quality System, Root Cause Analysis, Process Improvement, Quality Assurance, Continuous Improvement, Iso 13485, Software Documentation, Iso, Leadership.
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