Steven Hollingsworth

Director, Quality Regulatory Supply Chain @The Morel Company

Batesville, IN, US
MOBILE NUMBERS
+15•••••••70

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WORK HISTORY

Aug 2024 — Present

Director, Quality Regulatory Supply Chain @The Morel Company

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Batesville, IN, US

Responsible for all Quality Assurance, Regulatory Affairs, and Supply Chain activities for The Morel Company, medical device manufacturer of the Hercules Patient Repositioner. Serving as the company Quality Management Representative (QMR), lead all Quality, Regulatory, Supplier Management, and Purchasing responsibilities. Report to the V.P. of Operations and Product Development.

EDUCATION

1982 — 1986

South Dearborn High School (Aurora, IN)

High School, High School Academia

N/A

Indiana Wesleyan University

Master’s Degree, International Management

N/A

University of Cincinnati

Bachelor of Science - BS, Electrical and Electronics Engineering

SKILLS

Corrective and Preventive Action (Capa)21 Cfr Part 11Quality SystemGreen BeltBusiness AcquisitionDesign EngineeringFailure Mode and Effects Analysis (Fmea)Supplier QualitySix SigmaQuality AuditingLean TransformationAcquisition IntegrationMergers & AcquisitionsQuality AssuranceProject ManagementAuditingInternational Business LeadershipFmeaSoftware Quality AssuranceDesign AssuranceRoot Cause AnalysisBlack BeltValidationStrategic LeadershipAudio EngineeringElectrical EngineeringFdaSoftware VerificationDmaicMedical DevicesOperational Due DiligenceCapaIso 9000Engineering ManagementDue DiligenceQuality ManagementLean ManufacturingIso 13485Fda GmpRegulatory Affairs

ABOUT STEVEN HOLLINGSWORTH

Experienced professional with multidisciplinary experience leading global Engineering and Quality & Regulatory professionals.Have lead large organizations on a global scale as an Engineering Manager, R&D Core Team Leader, Post Market Surveillance Senior Manager, Regulatory Senior Manager, Director Compliance, Director Global Quality Systems, Director Global Supplier Quality, Director Technical Services, Director Global Design Assurance, and Director Mergers & Acquisitions.Extensive experience with FDA remediation activities and successfully clearing FDA Warning Letters.Have lead upwards of 20 FDA Inspections and ISO13485 Certification Audits.Six-Sigma Black Belt and Green Belt

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