Dave Klokowski

About Dave Klokowski

Core Qualifications:* Faculty Member at 1st Joint AHWP-RAPS Conference and CBI Product Complaints Congress presenting on Postmarket Surveillance Systems and writing effective MDR reports* Official FDA correspondent for GE Healthcare, managing registrations for 47 sites and 3600+ medical device listings via FDA Unified Registration and Listing System (FURLS)* Postmarket audit lead with direct auditor interfacing experience in multiple FDA inspections, notified body audits and other internal audits* Advanced training in Lean Six Sigma, Analytics/DMAIC and DFSS and sponsored 3 lean leaders in achieving black belts * Applied knowledge of CFR part 21, 820, 803 and 806, ISO 14971 and 13485, MEDDEV 2.12-1 and CFR 1020 performance standards for diagnostic X-ray (Subpart J)

Experience

1. Director of Product Quality - Magnetic Resonance

   GE HealthCare

   Jan 2020 — Present · Waukesha, WI, US

   Responsible for product quality strategy across the MR business, including the identification of key metrics/KPIs from the SBU bowler that define product quality relative to the Magnetic Resonance (MR) product to drive improved customer experience and satisfaction• Lead annual target setting and monitor progress by assembling metrics, analysis and presenting trends, drive problem solving reports (PSR) progress and continuous improvement actions. Respresentative for product quality for MR business leadership at monthly operating reviews (MOR) • Established key operating mechanisms to align and monitor product quality improvement projects and activities actions across region service, sourcing, manufacturing operations, product management and engineering.• Performed duties of PRRC at Waukesha South MR Design Site in 2022, managed local QA team and key responsibilities (NPI QA oversight, CAPA, holds and field actions) and hosted multiple notified body audits (G-MED, TUV) to demonstrate compliance and maintain certification for MDR, MDD, MDSAP, ISO13485, and ISO 9001 and responsible for leadership communication of required product holds and field actions.

Education

• University of Illinois Urbana-Champaign

  Bachleors, Microbiology

  1995 — 1999

Skills

• Fda
• Compliance
• 21 Cfr
• Dmaic
• Validation
• Regulatory Requirements
• Medical Imaging
• Fda Gmp
• Cross-Functional Team Leadership
• X-Ray
• Iso 14971
• U.s. Food and Drug Administration (Fda)
• Corrective and Preventive Action (Capa)
• Quality Assurance
• Quality System
• Quality Systems
• Design Control
• Medical Devices
• Capa
• Complaint Management
• Regulatory Affairs
• Iso 13485
• Six Sigma
• Quality Auditing
• Quality Management