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Work Background
Quality System Consulting & Contracting (www.qsc2.com)Principal Owner
Oct. 2025Florida, United StatesIf you have short-term (3 months), mid-term (6 months) or long-term (12 months or more) problems to solve, or needs to fill in the any of the following consulting circumstances or contracting scenarios, I can help. Regulatory Compliance FDA Audit Prep, Support, Results (mitigations) Notified Body Inspection Prep, Support, (mitigations) Internal Audit Prep, Support, Results (mitigations) Electronic Signatures, Electronic Records Processes Computer Software Assurance / Computerized System Validation Adverse Event Reporting / Post Market Surveillance / Complaint Handling / Investigations / Recalls Top Management and Quality System Representative Designations Quality System Leadership Product and Process Nonconformances Corrections, Corrective Action, Preventive Actions Product Risk Management Compliance Training Management Reviews Good Manufacturing Practices (GMP's) Quality System Maintenance / Process Development Design Controls, Document Controls, Change Management Software Development Lifecycle (IEC 62304) Formal Design Reviews Employee Competence
React HealthDirector QA RA
Jul. 2024 - Sep. 2025United States
React Health, formerly 3B Medical, Inc.Senior Design Quality Engineer
Feb. 2023 - Jul. 2024Sarasota, Florida, United States
Ascom AmericasQA Manager US
May. 2021 - Feb. 2023Bradenton, FL & Morrisville, NC
Ascom Sweden ABDirector Quality Assurance Regulatory Affairs
Apr. 2019 - Apr. 2021Bradenton, FL & Goteburg, Sweden
Ascom Sweden ABDirector Quality Assurance Regulatory Affairs
Apr. 2019 - Apr. 2021Bradenton, FL & Goteburg, Sweden
Ascom AmericasSite Manager, Deputy Director, QA / RA, Ascom Wireless, Ascom Patient Systems (US)
Jun. 2012 - Apr. 20199024 Town Center Parkway, Lakewood Ranch, Florida 34202
Pasco County Schools, Wiregrass Ranch High SchoolJV Baseball Coach, Assistant Varsity Baseball Coach
Jan. 2012 - Apr. 2016Wesley Chapel, FloridaHead JV 2014-2015, Assistant Varsity 2016
GE HealthcareSite Quality Leader
Oct. 2009 - Jun. 2012Site Quality Leader, Nurse Call Systems
GE HealthcareSite Quality Leader
Oct. 2009 - Jun. 2012Site Quality Leader, Nurse Call Systems
GE HealthcareQuality Engineer
Aug. 2007 - Jan. 20109024 Town Center Parkway, Lakewood Ranch, Florida 34202Work with product design programs & installed base engineering projects (bedside monitors) at the GEHC facilities in Tampa, Milwaukee & Helsinki to ensure compliance to GE Healthcare Quality Standards and Design Controls as well as US FDA (Food and Drug Administration) and regulatory (ISO 9001, ISO 13485) requirements. Support QA central teams in the implementation and deployment of new and updated compliance procedures to the GE Healthcare facilities in Helsinki, and the implementation and remediation of process and product level CAPA. Support internal & external (FDA & Notified Body) audits throughout multiple GE Healthcare facilities, & remediation of audit findings.
GE HealthcareQuality Engineer
Aug. 2007 - Jan. 20109024 Town Center Parkway, Lakewood Ranch, Florida 34202Work with product design programs & installed base engineering projects (bedside monitors) at the GEHC facilities in Tampa, Milwaukee & Helsinki to ensure compliance to GE Healthcare Quality Standards and Design Controls as well as US FDA (Food and Drug Administration) and regulatory (ISO 9001, ISO 13485) requirements. Support QA central teams in the implementation and deployment of new and updated compliance procedures to the GE Healthcare facilities in Helsinki, and the implementation and remediation of process and product level CAPA. Support internal & external (FDA & Notified Body) audits throughout multiple GE Healthcare facilities, & remediation of audit findings.
GE Medical SystemsLead Program Integrator Installed Base
Oct. 2002 - Aug. 2007Tampa, Florida, United StatesResponsible for the prioritization, scheduling and execution of installed base programs, including engineering design changes, product initiatives, field modifications and product compliance (regulatory and environmental). Manage a diverse international team of local, national and international (India) resources to support, execute, drive and implement through to operations, engineering design changes at every level, and across all engineering disciplines (electrical, software, and mechanical). Managed and drove programs to meet domestic and international regulatory WEEE (waste electrical and electronic equipment) and RoHS (Restriction of Hazardous Substance) compliance initiatives throughout the world.
GE Medical SystemsLead Program Integrator Installed Base
Oct. 2002 - Aug. 2007Tampa, Florida, United StatesResponsible for the prioritization, scheduling and execution of installed base programs, including engineering design changes, product initiatives, field modifications and product compliance (regulatory and environmental). Manage a diverse international team of local, national and international (India) resources to support, execute, drive and implement through to operations, engineering design changes at every level, and across all engineering disciplines (electrical, software, and mechanical). Managed and drove programs to meet domestic and international regulatory WEEE (waste electrical and electronic equipment) and RoHS (Restriction of Hazardous Substance) compliance initiatives throughout the world.
Quantitave Medicine Inc (Division of GE Healthcare)Software Engineer
Apr. 2000 - Oct. 2002Annapolis, Maryland, United States
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