Megan Viers
Senior Design Quality Engineer- New Product Development @Avanos Medical
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WORK HISTORY
Senior Design Quality Engineer- New Product Development @Avanos Medical
Alpharetta, GA, US
I am the Technical Quality lead for Risk Management and Design Control activates related to Medical Device New Product Development. Below are my key responsibilities- Facilitate and actively participate in the development of deliverables required for medical device product development ensuring adherence to the Avanos design control process- Development of the Risk Management files; includes Product Hazards Analysis, Design FMEA, Use FMEA & Process FMEA for new products- Development of Manufacturing Control Plan Realization documentation- Lead and ensure compliance to all risk management requirements- Actively participate in the development of statistical plans and rationale for design control activities/requirements- Actively partner with the project teams to facilitate the incorporation of all quality system elements, root cause analysis, corrective action and continuous improvement principles throughout the entire product redesign- Provides technical leadership in solving challenging technical problems related to quality issues and technologies- Support notified body and internal auditsI also have experience with submitting technical documentation to BSI for products requiring the CE certificate under the new EUMDR as well as experience with remediating the RMFs and DHFs to be EUMDR compliant.
EDUCATION
Southern Polytechnic State University
Bachelor of Science (BS), Industrial Engineering Technology
SKILLS
ABOUT MEGAN VIERS
I graduated Magna cum laude from Southern Polytechnic State University in May of 2015. I was awarded my Bachelor of Science in Industrial Engineering Technology with concentrations in Logistics and Quality Principles and a minor in Business Administration. Upon graduation I received certificates in Product Design and Six Sigma Green Belt. Right out of college I worked for Hitachi Automotive Systems Americas as a Quality Engineer for the Electronic Throttle Body at the Harrodsburg, Kentucky plant. I dealt mostly with the customer in addressing line and warranty returns, product and/or process changes and quality concerns. I then worked for Levolor (a Hunter Douglas company) in Atlanta, GA as a New Product Development Quality Engineer in the Quality Assurance department responsible for new product launches, product and process improvements and overall reduction of internal and external cost of failure. I am currently a New Product Development Engineer for the Technical Quality team in the Chronic Care business for Avanos Medical headquartered in Alpharetta, GA responsible for Risk Management and Design Control activates related to Medical Device New Product Development.
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