Quality Engineer Engineering
Resume:
CLAYTON J GALLAGHER
*******.**********@*****.*** 513-***-**** 958 Trellises Dr Apt 1117, Florence, KY 41042
EDUCATION
The Ohio State University, Columbus, OH; B.S. Chemical Engineering; Graduated: December 2015
WORK EXPERIENCE (Contract)
Regulatory Affairs Specialist, Integra LifeScience, Cincinnati, OH; July – Present
Work with design history files (DHF), risk management files and Tech Files as part of quality system
Facilitate the development, implementation and monitoring of the quality programs and policies
Perform quality and regulatory affairs related activities as needed to help ensure site compliance with FDA 21 CFR 820 and other domestic and international requirements
Provide internal customers with regulatory information that may include product labels and UDI information
Assist with internal documentation audits and helped support BSI MDD audit
Associate Quality Engineer, Leica Biosystems (Mammotome), Cincinnati, OH; June – December 2016
Develop risk management plans, reports, and utilize risk management tools such as FMEAs in compliance with BS EN ISO 14971:2012
Perform yearly Post Market Surveillance requirements for risk management files as required within BS EN ISO 14971:2012
Oversaw multiple simultaneous Value Analysis/Value Engineering (VAVE) and Sustaining Engineering projects as product Quality Engineer to ensure projects met requirements of 21 CFR 820
Coordinated global capital product complaints investigation reporting from multiple third party service providers
Applied sound systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues under the direction of other team members
Assists with the coordination of elements of investigations regarding customer complaints
Supports the validation of product designs, manufacturing processes, and procedures required for the production and delivery of finished product
Provided backroom support during a FDA QSIT audit and during an ISO 13485:2012 recertification audit
INTERNSHIP EXPERIENCE
Sugar Creek Packing Co., 4585 Muhlhauser Rd Hamilton, OH; May - August 2015
Interned in the safety department for a medium sized food and packing company with a focus in consumer meats.
Analyzed new and existing equipment for possible hazards and accessed need for machine guarding
Created training videos for new hires, uploaded into existing online system
Updated Safety Data Sheets (MSD) to new MSDS global standard in online system
Materion Brush Inc., 14710 Elmore, OH; January - May 2014
Interned as a process engineer for a company that is one of only two producers of beryllium copper in the world. Collaborated with all levels of management and production staff as part of assigned projects.
Analyzed five years of production data to assess quality trends to determine production best practices
Monitored furnace particulate levels to track furnace lining lifespan
Reviewed standard operating procedures (SOP), including performing personal interviews, to assess SOP compliance and effectiveness
Researched and tested viable filtration options, assessing cost effectiveness, longevity and ease of use
Worked with lab technicians, using Lean/Six Sigma tools to determine validity of quality controls
COLLEGE RESEARCH
Polymer Research Group; September 2014 – December 2015
Undergraduate Research Assistant, Ohio State Chemical and Biomolecular Engineering Department
Assessed properties of carbon nanofiber substitutes and modeled properties of new materials with an aim of moving these materials into industrial applications
Explored mechanical properties of polymer composites and determined which compounding method lead to better nanofiber distribution
TECHNICAL AND ACADEMIC QUALIFICATIONS
Chemical and biomolecular-related courses: organic chemistry, mass and energy transport, thermodynamics, kinetics, separations, design of experiment, modeling/simulation, and polymer processing
Computer and technical skills: MATLAB, Windows Office, ChemCAD, Minitab, JMP, Q-Pulse, CAD, and DOE
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