Quality Engineer Medical Device

SUZANNAH SCHIEFLA

269-***-**** - ************@*****.***

PROFESSIONAL SUMMARY

Highly personable and motivated individual with a passion for problem solving, connecting with others, and community involvement. Focused and driven with aptitude for process improvement. Dedicated to going above and beyond to mitigate risk and improve quality. SKILLS

Medical Device Experience

Supplier Negotiation & Relations

Project Management

Six Sigma Green Belt

Interdisciplinary Collaboration

Public Speaking and Presentations

Technical Writing

Rapid Learning Cycle Methodology

Human Subject Testing

Test Method Development & Verification

Prototype Production

Microsoft Project & Trello

Consumer Research Analysis

Mental Health First Aid Certified

Root Cause Analysis

Control Plan Development

Team Leadership

Quality Documentation

PPAP Submissions

Product Design

Relationship Building

WORK HISTORY

09/2023 to 03/2024 Quality Engineer

Pratt & Whitney Aircraft – Lansing, MI

Contributed to root cause analysis to determine core reason for failures and errors.

Helped run a clinic with other quality engineers. Collaborated with floor workers to understand Quality Notifications and then monitored their progress through SAP.

Worked to lose approximately 300 open quality notifications, saving time and expenses. 03/2023 to 05/2023 Project Manager

Stryker Instruments Contractor

Managed a diverse team of 10 individuals project tasks and kept a project on budget and timeline using Microsoft project and Trello

Leveraged skills in communication and relationship building to connect with team members

Skills in Technical writing and my medical device experience were used often generate instructions for use as well as to help teammates complete their work. 04/2022 to 11/2022 Project Engineer

Flexfab

Managed personal projects including the design of a series of experiments to understand if the current glue Flexfab is using to bond PPS plastic to PPS plastic is truly their best option

Identified three viable alternative glues through managing supplier relationships and tapping into formerly established relationships.

07/2021 to 03/2022 Supplier Quality Engineer

Viking Corporation

Managed half of Viking’s Supplier relationships and worked in manufacturing, logistics, and supply chain management to assess quality and ensure all products were free from defects and in compliance with engineering and manufacturing specifications and government standards

Utilized solid works to view product drawings and to help make informed quality decisions

Worked to resolve any quality issues and provide guidance on process enhancements and improvements

Accepted PPAP documentation for new products and managed the PPAP inventory. 06/2019 to 07/2021 Product Development Engineer

Kimberly-Clark

Support critical new product design and process development initiatives for Kimberly- Clark's class II medical devices

Coordinated a process improvement quality initiative in Nogales, Mexico for U by Kotex Tampons saving approximately 16 million dollars of nationwide business.

Wrote and revised specifications for regular sized product guided by data and learnings from a series of design of experiments.

EDUCATION

BS Chemical Engineering

Michigan Technological University - Houghton, MI

Minor: Writing

GPA: 3.94

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