Jorge González
Reynosa
Summary
Mechanical engineer with 25 years of experience implementing quality solutions in the manufacturing industry. Medical devices, ISO 13485, Quality Management Systems IATF 16949, Lead Auditor certified, Project Management, Risk Assessment.
Overview
16
16
years of professional experience
Work History
Quality Superintendent
Reichert Technologies
01.2020 - 01.2025
- Responsible for 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.)
- World leader in diagnostic refracting and examining ophthalmic instruments for the eye care professional
Senior Quality Engineer
Parken
01.2018 - 01.2020
- Red X projects on customer complaints, reduce 50% complaints during a 6 months period.
- Scrap reduction on contributors from 14% to 7% during a three-month period
- Part of a world leader automotive company, customer satisfaction, General Motors, Ford, Fiat Chrysler.
Project Manager
Corning Optical Communications (Optical Fiber)
01.2015 - 01.2018
- Appropriation requests, capital funding request-costs justifications.
- Main project for the acquisition of air compressed system equipment- $550K, Project saving costs- $140K annually, recovering capital investment.
- 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
Process Engineer
BSN Medical
01.2012 - 01.2015
- 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.
- Global leader in wound care & related vascular diseases, lymphology and non-invasive orthopedic products.
Quality Engineer
Fresenius Medical Care
01.2009 - 01.2012
- 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 accelerate 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.
- Medical company specialized in the production of medical supplies, especially for kidney dialysis.
Education
Bachelor - Mechanical Engineer
Technological Institute – Tamaulipas
01.1993
Skills
- Transfer projects
- Validation
- Project management
- Equipment acquisition
- Electrical installations
- Compressed air systems
- Shelf-life testing
- Material analysis
- Sterilization processes
- Risk assessment
- Crossed contamination
Timeline
Quality Superintendent
Reichert Technologies
01.2020 - 01.2025
Senior Quality Engineer
Parken
01.2018 - 01.2020
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
Bachelor - Mechanical Engineer
Technological Institute – Tamaulipas