George Pasinski

About George Pasinski

Over thirty years experience as a results oriented Quality Management Leader with international medical products companies. ASQ Certified Manager of Quality / Organizational Excellence, Certified Quality Engineer, Certified Medical Device Auditor, and Certified Six Sigma Black Belt.Specialties:~Application of Lean Six Sigma and Quality Engineering Tools~Implementation of Effective Organizational Strategies~Implementation of FDA Pharmaceutical cGMP / FDA Medical Device QSR / EU MDR / ISO13485~Risk Management for Product and Process~New Product Commercialization and Design Controls~Servicing Internal / External Quality Audits and FDA Inspections~Management in a Matrix Environment~Complex Process Problem Resolution~Design and Execution of Process / Product Validations~Strong Verbal and Written Communication Skills

Experience

1. Director Therapeutic Combination Products & Medical Devices, R & d Quality Assurance

   AbbVie

   Sep 2023 — Present

   Primarily responsible for setting global vision and strategy for Medical Device and Combination Products R&D QA. Execute the Quality System requirements to ensure that a diverse range of devices essential for the advancement of the R&D pipeline are developed compliant with worldwide quality and regulatory requirements. Lead a global team of quality professionals responsible for quality oversight of MedicalDevice and Combination Products development.

Education

• Northern Illinois University

  BS, Biochemistry

  1986 — 1991