Victor Szepe                                                                                        

Sr. 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 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...

• Sr. 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. in Electrical Engineering                University of Utah

CONTINUING EDUCATION...

• 21 CFR Parts 210, 211, 806, 820
• Certified Quality Manager (CQM)
• ISO Lead Assessor
• Six Sigma DMAIC