Victor Szepe

Senior Quality Engineer

Victor is a Certified Quality Engineer (ASQ CQE), Certified Quality Auditor (ASQ CQA), and Certified Manager of Quality and Operational Excellence (ASQ CMQ/OE) with more than 12 years industry experience. He is an expert in quality systems and improvement tools for fabrication and assembly processes with extensive mechanical and electrical engineering experience. Victor is a creative problem solver/catalyst for ISO and GMP quality systems, including widespread application of statistics.

EXPERIENCE…
  • Managed and coordinated transfer of product design and process technologies to contract manufacturers for New Product Introductions (NPI). Generated and maintained Design History Files (DHFs).
  • Developed and executed IQ/OQ/PQ/PPQs for medical device manufacturing operations. Validated complex electro-mechanical device assembly processes to FDA QSR.
  • Generated and updated numerous FMEAs for Class II / III Medical Device Processes, including update of Design FMEA.
  • Developed, executed, and reported Test Method Validations to support Process and Design V&V activities.
  • Represented Senior Management Team in presentations of Statistical Process Control and Just-in-Time philosophies. Adept in Lean Manufacturing, Multi-Tasking, and Strategic Cost Reduction.
  • Coordinated and/or led quality improvement teams to address quality and reliability issues. Reduced component defect rates from initial 3-8% to less than 0.1%.
  • Re-engineered critical component manufacturing plan, including operator actions, materials, fixtures, and tooling. Improved yields from 5% to 99% within three months.
  • Accomplished process and product quality improvements through customization of receiving inspection, in-process, and pre-shipment inspection plans, including on-going reliability monitors and out-of-box inspections. Set up and met PPM targets for internal and OEM customers.
  • Designed and implemented Process Management Planning for various processes, including detailed linkage of operator action/reaction, design documentation, and risk assessment.
  • Identified and generated procedural improvements in production systems for compliance with ISO9000 and/or FDA Good Manufacturing Practices (GMP).
  • Authored several Supplier Quality Handbooks detailing business flows, approval and qualification processes, and general expectations for suppliers, including First Article checklists, Process Management Plans, and supplier-performed validations.
  • Provided Statistical Process Control (SPC) training/consulting for manufacturing supervisors.
  • Introduced statistics based decision-making in medical device product/process qualification and validation and routine variables based lot acceptance plans.
  • Extended Configuration Management II principles to the product change process. Assisted in definition of Product Life Cycle for new and existing products.
  • Designed and generated Material Review Board (MRB) and Corrective Action tracking systems.
  • Managed performance of injection molded plastic, extrusions, PCB assemblies, programmable memory, membrane keyboards, complex machining, metal castings, polymers, electronic displays, rollstock adhesives, and formed packaging.
  • Developed supplier appraisal and ranking process for initial supplier selection by Engineering and Materials. Consolidated component and subassembly sources within technical roadmaps, attaining 80% reduction in supplier base and 50% savings in Cost of Quality.
  • Implemented problem-part tracking and response systems for satellite manufacturing sites, reducing response time 80% and improving accuracy 100%.
  • Completed training and accomplished numerous (100+) site QMS audits per ISO9000, 21CFR820, ISO13485 (US, CMDR, and/or MDD focus), and ISO17025.
POSITIONS HELD…
  • Senior Quality Engineer – BioTeknica, Inc.
  • Independent Consultant – Szepe Consulting
  • Manager, Components Engineering – Iomega Corp
  • Sr. Engineer, Supplier Quality Assurance – Valley Lab, Inc.
  • Senior Manager, Supplier Quality Assurance – Texas Instruments
EDUCATION…
  • B.S., Electrical Engineering – University of Utah
CONTINUING EDUCATION…
  • 21 CFR Parts 210, 211, 806, 820
  • Certified Quality Manager (CQM)
  • ISO Lead Assessor
  • Six Sigma DMAIC