Summary
Overview
Work History
Education
Skills
Certification
Affiliations
Vocal Performance
Languages
Timeline
Generic

COLEEN FOX

Summary

Driven Quality Engineer with great knowledge of process change documentation and root cause analysis. Ambitious and driven individual with extensive training in Solidworks and IQ, OQ, and PQ protocols. Dedicated to best-in-class work.

Overview

8
8
years of professional experience
1
1
Certification

Work History

Quality Engineer

Mag Specialties Inc
11.2021 - 02.2023
  • Management of entire quality system for Metal Extrusion Company
  • Analyzed and interpreted data to identify trends and recommend improvements in key customer PPAP.
  • Designed and implemented quality control processes to facilitate customer satisfaction such as CAR and PAR.
  • Led problem-solving activities to quickly identify and permanently resolve quality and productivity issues.
  • Coordinated with quality control staff to complete inspections and ISO 9001:2015 and IATF 16949 compliance audits.

Senior Quality Engineer

Abbott Contractor
10.2020 - 10.2021
  • Conducted Gap Assessments on PTR documents of five major product lines within Cardiac Rhythm Management department
  • Knowledgeable of China regulations and Medical Device Regulation (MDR) design and development requirements
  • Gained experience with non-US Regulations such as [Industry standards, Quality Systems Regulation, Documentation Methods Best Practices]
  • Reviewed Risk Management, Design Input/Output Matrices, and other technical documents
  • Provided input for harmonization of legacy files
  • Coordinated with cross functional, transcontinental teams
  • Supported quality team members during corrective action updates.

Zimmer Biomet Contractor
11.2019 - 03.2020
  • Assessed updates to the Design History Files (DHF) of four major product lines
  • Knowledgeable of EU Medical Device Directive (MDD) and Medical Device Regulation (MDR) design and development requirements
  • Gained experience with non-US Regulations such as [Industry standards, Quality Systems Regulation, Documentation Methods Best Practices]
  • Reviewed Risk Management, Design Input/Output Matrices, and other technical documents
  • Provided input for harmonization of legacy files
  • Coordinated with cross functional, transcontinental teams

Quality Assurance Analyst

Cognizant Technology Solutions
07.2016 - 07.2019
  • Executed functional requirement gathering, planned and developed test scripts as part of a Software Development/QA environment
  • Consulted with client to create FDA-qualified IQ, OQ, PQ Documentation
  • Test Execution and verification of shipping website created using cross-functional teamwork
  • Created and Tested shipping website for $20 Billion company and responsible for updated project manuals and technical documentation used by Chief Information Officer
  • Ensured all of regulatory requirements, to include accrediting bodies, federal, state and local requirements and Cognizant's policies

Product Design Engineer

School of Biological and Health Systems Engineering
08.2015 - 05.2016
  • A hands-on approach of DOE, design and manufacturing as per FDA standards, verification and validation design and process, project management skills, cross-functional teamwork, DFMA, risk analysis, and FMEA
  • Monitored, installed and tested system components
  • Designed, tested and evaluated mechanical devices and systems including DOE, FMEA, and DFMA in a cross-functional team working on prosthetic limb design
  • Conducted research to test and analyze equipment and system feasibility, design, solidworks use, operation and performance
  • Conferred with team engineers and other personnel to implement operating procedures, resolve system malfunctions, and provide technical information

Education

Bachelor of Science - Engineering: Biomedical Engineering

Arizona State University
Tempe
08.2016

Summer School - Regenerative Medicine

University of Pittsburgh
Pittsburgh, PA
06.2015

Skills

  • 3D Printing
  • Laser cutting
  • C
  • CAD Dimensioning and Tolerance
  • Experimental Design
  • JavaScript
  • Market analysis
  • Matlab
  • Detail oriented
  • Strong decision maker
  • Risk analysis
  • Solidworks/CAD software expert
  • Validation and documentation
  • Project Management
  • FEA and failure analysis
  • Technical writing
  • Complex problem-solver
  • Process Control Documentation
  • Time Management
  • Root Cause Analysis
  • Complex Problem-Solving
  • Quality Improvement Strategy
  • Risk Management

Certification


  • Certified Yellow Belt, GoLeanSixSigma.com - 2021
  • PPAP-Production Part Approval Process Training - 2022
  • Certified Solidworks Professional, Solidworks - 2014
  • ISO 9001:2015 Lead Auditor (Quality Management System)Training Course, Cavendish Scott - 2022

Affiliations


  • Society of Women Engineers
  • Member Alumni Association Arizona State University

Vocal Performance

Avid performer for 16 years

Languages

Spanish
Limited Working
German
Elementary

Timeline

Quality Engineer

Mag Specialties Inc
11.2021 - 02.2023

Senior Quality Engineer

Abbott Contractor
10.2020 - 10.2021

Zimmer Biomet Contractor
11.2019 - 03.2020

Quality Assurance Analyst

Cognizant Technology Solutions
07.2016 - 07.2019

Product Design Engineer

School of Biological and Health Systems Engineering
08.2015 - 05.2016

Bachelor of Science - Engineering: Biomedical Engineering

Arizona State University

Summer School - Regenerative Medicine

University of Pittsburgh

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COLEEN FOX