Summary
Overview
Work History
Education
Skills
Timeline
Generic

Patricia N. Sanchez

El Paso,USA

Summary

Highly-motivated employee with desire to take on new challenges. Strong work ethic, adaptability, and exceptional interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills.

Overview

12
12
years of professional experience

Work History

QATech

Cardinal Health
10.2021 - Current
  • Developed and implemented operational procedures to ensure quality standards are met.
  • Developed and implemented quality assurance processes to ensure product compliance with customer requirements (MCD process, and lamination process).
  • Performed and providing the follow up of the IQ/OQ/PQ, SOP, AQL, Visual AID, Calibrations and environmental monitoring of the N95 facemask project.
  • Complaints, NC, Root causes analysis.
  • Internal and external Audits.
  • Participated in cross-functional teams focused on improving product quality.
  • BSI Audits

Quality System and Regulatory Compliance

Steris AST
03.2019 - 10.2021
  • Developed and implemented quality assurance processes to ensure product compliance with customer requirements.
  • Continuous improvement / project Management
  • SOP, Process, Visual AID, Engineering Change Orders related to procedures updates, and training.
  • Validation, NC, SCARs, 8D, Risk assessment.
  • Environmental Monitoring, BI’s room handle
  • Evaluating process flow of the loads and release the COPs.
  • Review of the final product documentation customer standards spec.
  • EO (Ethylene Oxide) and Gamma Process review and support.
  • Review the Opportunity reports from production to discard 8D.
  • Update the specification books of the customers after each validation
  • Working under FDA/BSI/ QSR regulation.
  • External Audits according to regulatory standards ISO13485, US FDA 21CFR part 820, US FDA 21CFR Part 210/211, US FDA 21 CFR
  • Internal and External Audits (FDA/ OSHA/BSI).
  • Customer Service (Daily meeting for points of view, complaints and improvements)
  • Participated in cross-functional teams focused on improving product quality.

Quality Engineer Technician lead

GE Healthcare
El Paso, USA
06.2016 - 03.2019
  • Implementation and following of the QMS
  • Create and implement Product audit, Process audit, and System Audits; FPI, FY, FPY.
  • Project development and implementation of design changes (product and process)
  • Establish volume sample test according to the RAW material (inbound) quantity receipt, or if the PN is 'safety' OR 'FAI' creating documentation requested by system (poka-yoke implemented, no system acceptance without folio 'safety' document.)
  • Making reports of errors found (trends, KPIs analysis) to make improvements and redesigns processes.
  • Control, handling, and segregation of all the returned goods to the warehouse (RMA process).
  • Processing the OBF according to the FDA procedures. (Decontamination devices-complaint review- evaluation - customer resolution- Communication with the manufacture plant in USA or Mexico; and provide evaluating result- final disposition of the unit).
  • Creating documentation (NCMR) and handling of Non-Conformance material.
  • Continues improvement; redesign complete process (from job responsibilities – to layout flow process) inventory Kanban racks, database, customer service guidance, tools use.
  • Issue quality inspection requested for COC, Including frequency, sample size, and techniques of measurement.
  • Supporting QMI (sadistically performance of the quality department), RMA Daily Report, Inventory reports, and production reports, including causes analyzing and correction actions.
  • Control Plans, Process Capabilities, SQL
  • Training new personnel in different areas of quality.
  • Hazard procedures.
  • Continuing improvement to make easy and safety the way work of the team (Cutting the time of the process and waste movement).
  • Inventory Reduction (follow up of transactions and clarifications RMI, WIP).

Quality Engineer Tech. Lead

Sanmina Corp
El Paso, USA
01.2013 - 06.2016
  • Responsible for the development and implementation of QMS.
  • Experience with process validation IQ, OQ, PQ.
  • El Paso Mainboard Project Lead: Using DMAIC (Define, measure, analyze, improve and control) Reducing the claims for scanners with intermittence. Searching causes in the managing of the CPU materials department and the managing of the manufacturing and repair personnel in the lines. Also making test in the packing and delivery products through the carriers.
  • ESD procedures and calibrations / RoHS requirement and rules.
  • Working to main board (components) level; Juarez manufacturing process and El Paso Repair process (units performance issues reported for the customer intermittent etc.)
  • Collaborated with clients from concept through final delivery of product or service, or customer claims.
  • Writing work instruction and /or changes if the process required it.
  • First product inspection according to the product specs.
  • Monitoring FAI trend, and final inspections/audits providing weekly, monthly, and annual QA reports.
  • Provide disposition to Non-Conforming Material. Requesting supplier 8D id the issue require it.
  • Leading corrective and/or preventive action to resolve quality concerns.
  • Participate in ISO-14001, ISO9001, 5s, and Lean Six Sigma audits.
  • Material disposition movement and storage.
  • Issue RMA (return or scrap) authorization to the Customer.
  • Error prevention Poka-Yoke implementation, containment actions, 3up follow up, and preventive actions.
  • Preparing and submitting corrective actions, through the use problem solving techniques (5Whys, 8D, Pareto, Fishbone analysis, etc.) and able to identify root and causes.
  • Periodically Audits in Work Instructions, to ensure that they are followed or modified when necessary.
  • Review, verify and maintain accurate data and documentation in all areas assigned (Data, reports, KPI's, Quality alerts, Visual AID, WI, DCN, meeting minutes, training logs, Calibration Logs) and in accordance with established quality plans, policy and procedures.
  • Support in SCARs, CAPA, RTV and Document Control.
  • Supporting FMEA in minimizing failures problem getting reduction cost benefits.

Education

Six Sigma Green Belt Certificated -

Institute of Industrial Engineers
George, IA
01.2010

BS - Industrial Engineering, Operation Supply

The University of Texas At El Paso
El Paso, TX

Skills

  • Equipment calibration and process
  • Excel,Word,PPT,Drawing, Teams
  • Engineering/project management experie
  • Statistical process control
  • Agile/My Learning / Smartsolve
  • Data Analysis
  • Technical expertise and leadership for daily Quality operations
  • Critical and objective thinking
  • Decision Making
  • Regulatory compliance

Timeline

QATech

Cardinal Health
10.2021 - Current

Quality System and Regulatory Compliance

Steris AST
03.2019 - 10.2021

Quality Engineer Technician lead

GE Healthcare
06.2016 - 03.2019

Quality Engineer Tech. Lead

Sanmina Corp
01.2013 - 06.2016

Six Sigma Green Belt Certificated -

Institute of Industrial Engineers

BS - Industrial Engineering, Operation Supply

The University of Texas At El Paso

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