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Quality Engineer Chemical Engineering

Kalamazoo, Michigan, United States
August 21, 2018

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Elizabeth A. Rusin

**** **** **** ***** **** 716-***-****

Richland, MI 49083


Experienced Advanced Quality Engineer, looking to relocate, with a demonstrated history of working in the medical device industry. Skilled in Minitab, Root Cause Analysis, Problem Solving, Quality Assurance/ Regulatory Guidance, Microsoft Excel, Customer Service, and Engineering. Strong quality assurance professional with Dual Degrees focused in Chemical Engineering and Biomedical Sciences from Western Michigan University. Seeking to have significant interaction with clinicians, customers and internal teams to support technical and commercial efforts to develop and market products that make a difference in healthcare. Passionate for medical device design to improve equipment and practices; to bring equal and advanced medical care globally. Strong qualities in leadership, ideation generation, focus, learning, putting ideas in to motion, and driving results. Education

Western Michigan University – Kalamazoo, MI

Major Degrees Minor Degrees

Bachelor of Science, Chemical Engineering - December 2015 Mathematics Bachelor of Science, Biomedical Sciences - December 2015 Chemistry Certification

Fundamentals of Geometric Dimensioning and Tolerancing Technician Level completion of the Fundamentals of GD&T to the 1994 Standard. Accomplishments

Kalsec, Inc. - Kalamazoo, MI 2015

Senior Design Project

Named Team Lead in real-world challenge to design a device and develop associated processes to test the viability of an isolated compound via froth flotation distillation. Responsible for developing a technical solution to a manufacturing problem as well as preparation of compelling business case that supported commercial viability of implementation.

Roswell Park Cancer Institute – Buffalo, NY 2007 Gynecologic Oncology Initiative

Tasked with organizing and presenting key data to best demonstrate clinician’s key findings in advanced cancer research project. Developed relationships with the primary clinical investigator; built trust by delivering consistent results that enabled autonomous activity. Proposed graphical data presentation was included in final publication with a personal acknowledgement.

“A Gynecologic Oncology Group Study of Platinum-DNA Adducts and Excision Repair Cross-Complementation Group 1 Expression in Optimal, Stage III Epithelial Ovarian Cancer Treated with Platinum-Taxane Chemotherapy” (K.M. Darcy, C. Tian, E. Reed) Experience

Stryker Instruments – Kalamazoo, MI 2016 - Present New Product Development Advanced Quality Engineer (NPD AQE) Work with a diverse new product development team from R&D to Marketing and Production to execute quality assurance engineering work and provide inputs throughout the New Product Development for design quality and process quality.

• Develop Deign History File and Design Master Record documentation creation for the Risk Management File (RMF), Design Input/output Verification and Validation (DIOVV), Failure Mode Criticality Analysis (FMECA), design reviews, human factors engineering reports, voice of customer validation studies, and verification and validation testing protocols

• Lead Human Factor’s engineering and design during research development of products.

• Collaborate with design engineers and process validation to develop robust verification and validation test strategies to ensure a safe, reliable product.

• Lead risk analysis and develop strategies for risk mitigation (RMF ownership)

• Execute to Stryker’s Quality System for New Product Development and guide teams through the quality system to ensure products are developed in compliance to their procedures and the requirements of the FDA, ISO, and other regulatory bodies.

• Drive supplier development activities surrounding the Production Part Approval Process (PPAP).

• Active participation of all activities surrounding product launch, including driving non-conformities to resolution


• Worked alongside operations and production teams on documentation, training, and compliance to ensure a successful product launch. (PLFU).

American Eagle Outfitters – Kalamazoo, MI / Buffalo, NY 2009 - 2017 Lead Sales Associate

Advanced from fill-in position to Lead Associate tasked with aggressive sales performance objectives. Built customer relationships that drove repeat sales.

• Consistently exceeded personal sales targets of in-store products, resulting in achievement of multiple bonuses

• Consistently led district in conversion of customers to profitable AE credit card

• Expanded sales by using directing in-store customers to website for supplemental follow-up sales

• Trained and mentored new associates: led by experience, with role play and one-on-one coaching

• Key participant in management review sessions. Proposed and implemented new ideas to increase sales.

Animal Rescue Project – Kalamazoo, MI 2013 - Present Fundraising Chair; Adoption Facilitator

Revamped and revitalized waning legacy fundraising efforts that resulted in significant year-to-year increases in donations received. Successfully turned around “Pup of the Game” promotion at Kalamazoo sporting events; expanded program and introduced “Rent-A-Pup” at Western Michigan University student gatherings.

• Organized and led volunteer groups in fundraising initiatives

• Secured new sponsors to expand fundraising opportunities and events

Girls on the Run, Heart & Sole – Kalamazoo, MI 2016 – Present Head Coach

Led teams of 3rd through 8th grade girls in physical based activities to inspire health, joy, self-assurance, and fun. Encourage social and emotional learning through both team and one-on-one activities.

• Facilitate discussion, problem solving, and girls to be confident leaders

• Create positive connections with peers and adults, making meaningful contributions Activities

• Society of Women Engineers – Recruiter, Fundraiser Chair • American Institute of Chemical Eng. - Member

• Women in Stryker Engineering (WISE)- Mentor, Member

• Stryker Women’s Network (SWN)- Member

• Kappa Alpha Theta – Alumna

• NSA Slow Pitch Softball- Coach, Team member

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