Steve Gompertz

About Steve Gompertz

Steve Gompertz is a leader in Quality Systems management. His career includes roles in quality systems development and implementation, project management, engineering automation, configuration management, audit, and software development for companies including St. Jude Medical, Boston Scientific, Medtronic, Vital Images, and Control Data. He holds a B.S. in Mechanical Engineering from Lehigh University, and certifications in quality management, biomedical auditing, project management, and configuration management.Mr. Gompertz has developed a Quality Systems Capability Model merging Risk Management and CMMI concepts to create the only method available to quantitatively measure a quality system\'s effectiveness and potential. He is also responsible for coining the term,\"dysfunctional compliance\" to describe the situation where a company meets all regulatory and statutory requirements but still experiences significant quality issues due to not addressing quality from a true systems perspective.StrengthsFinder Results: Ideation, Strategic, Significance, Maximizer, RelatorSpecialties: Quality Systems Design, Audit, & Capability AssessmentProcess ImprovementProject ManagementProcedure & Forms DevelopmentQuality Systems Guidance and TrainingProduct Data Management (PDM) Systems ImplementationMechanical Design Automation

Experience

1. Partner, Operations and Resourcing

   QRx Partners

   Apr 2020 — Present · Minneapolis, MN, US

   Providing consulting expertise from over two decades of medical device industry experience to help companies realize business value as well as compliance from their quality systems.Services Offered:• Quality System Assessment• Audit Preparation• Quality System Development/Remediation• SOP & Forms Development• Regulatory Body Response Guidance• Quality Systems EducationSee Projects section below for examples of projects undertaken for clients.

Education

• Lehigh University

  BSME, Mechanical Engineering

• University of St. Thomas

  Mini-MBA in Medical Technology Management Certificate

Skills

• Quality System
• Cross-Functional Team Leadership
• Iso 13485
• Fda
• Medical Devices
• Capa
• Quality Management
• Design Control
• Process Improvement
• Management
• Project Management
• Document Management
• Leadership
• Quality Assurance
• Strategy
• Auditing
• Product Lifecycle Management
• Configuration Management
• Change Management
• Risk Management
• Coaching
• Iso 14971
• Cold Chain
• Iso 9001
• U.s. Food and Drug Administration (Fda)
• Business Process Improvement