Summary
Overview
Work History
Education
Skills
Timeline
Generic

Jorge González

Vista Hermosa

Summary

Quality superintendent with 25 years of experience implementing quality solutions in the manufacturing industry. Medical devices on ISO 13485:2016, Automotive on ISO TS-16949. Lead Auditor certified, Project Management, Risk Assessment.

Overview

25
25
years of professional experience

Work History

Quality Superintendent

Reichert Technologies
01.2020 - Current
  • Company Overview: World leader in diagnostic refracting and examining ophthalmic instruments for the eye care professional
  • Responsible of the Quality Management System of the Reynosa operation.
  • Lead activities of the Quality Department supporting the planning and attainment of Quality targets (KPI’s).
  • Supervise Quality Engineers and Technicians
  • Led overall corrective actions looking for continual improvement based on KPI’s or customer feedback.
  • Internal Audits, SGS compliance audits, supplier audits.
  • Follow up on overall continuous improvement projects making sure they are completed on time.
  • IOQ Validation projects
  • Quality planning (personnel, tools, training, budget, etc)

Project Manager

Corning Optical Communications (Optical Fiber)
01.2015 - 01.2018
  • Part of a world leader company with 5000 employees leading capital projects for acquisition of new utilities and services from the range of 20K to 300K
  • Appropriation requests, capital funding request-costs justifications.
  • Main project for the acquisition of an air compressed system equipment- $550K, Project saving costs- $140K annually, recovering capital investment.

Process Engineer

BSN Medical
01.2012 - 01.2015
  • Company Overview: Global leader in wound care & related vascular diseases, lymphology and non-invasive orthopaedic products.
  • IQ, OQ, PQ validation projects- compliance with CFR 21 Part 820.
  • Internal and external audits on the Quality Management System (QMS)-ISO 13485.
  • Validate the compression therapy process and Orthopedics Soft Goods consisting in 150 equipment devices- 500 employees.
  • Risk assessment analysis on fracture management products containing 90% of potential failure modes inside the business.

Quality Engineer

Fresenius Medical Care
01.2009 - 01.2012
  • Company Overview: Medical company specialized in the production of medical supplies, especially for kidney dialysis.
  • Blood lines and peritoneal dialysis products as well as shelf life through accelerated aging studies.
  • Auditor for ISO 13485 (cGMP).
  • Project for shelf life confirmation for 120 different products subject to accelerated aging generating protocols for functional testing.
  • Conducted contamination risk assessment project in three plants through an extensive revision of every process. Resulting document was documented as regulatory evidence.

Sr. Quality Engineer

ThermoFisher Scientific (Metal-Mechanic)
01.2006 - 01.2009
  • Senior Quality supervising 22 employees in three shifts ensuring compliance with customer requirements for sales over 175 million USD
  • Leading quality projects for the plant and participated actively in product and equipment transfers.
  • Attended an average of 60 customer complaints weekly, implement corrective actions lowering product returns by 20% during 2009.

Continuous Improvement Engineer

Delphi Automotive Systems
01.2001 - 01.2006
  • Started as a technician, promoted in 2003 to continuous improvement engineer and selected among 25 engineers to be trained in Shainin tools for solving problems.
  • Customer complaints, use of 8D methodology and Shainin tools, root cause analysis, follow up with the multidisciplinary team on corrective actions.
  • Multiple visits to GM assembly plant in Ontario, Canada for model year changes.
  • Follow up on top five worst PPM’s contributors with projects based on Shainin methodologies impacting $25K annually in scrap costs.

Education

Bachelor - Mechanical Engineer

Technological Institute – Tamaulipas
01.1993

Skills

  • Experience with transfer projects moving medical devices Validation
  • Major capital project for the acquisition of new equipment, electrical installations, and compressed air system for the production area of a new manufacturing plant
  • Shelf Life Testing Project - Organized products into groups by analyzing common materials, sterilization processes and intended use
  • Risk Assessment Project for crossed contamination at Fresenius Medical Care

Timeline

Quality Superintendent

Reichert Technologies
01.2020 - Current

Project Manager

Corning Optical Communications (Optical Fiber)
01.2015 - 01.2018

Process Engineer

BSN Medical
01.2012 - 01.2015

Quality Engineer

Fresenius Medical Care
01.2009 - 01.2012

Sr. Quality Engineer

ThermoFisher Scientific (Metal-Mechanic)
01.2006 - 01.2009

Continuous Improvement Engineer

Delphi Automotive Systems
01.2001 - 01.2006

Bachelor - Mechanical Engineer

Technological Institute – Tamaulipas
Jorge González