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.
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