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Supplier Quality Engineer Resume Example

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SUPPLIER QUALITY ENGINEER
Summary

Biomedical Innovation and Development Master's student and a business-savvy strategic problem solver with four years of industry experience and a passion for healthcare innovation. In working on my thesis project, I am rapidly gaining market, reimbursement, and regulatory landscape analysis, ethnographic research, and product design development skills while creating a value-based innovative solution in the field of Emergency Medicine.

Skills
  • ISO 9001/13485, 21 CFR 820, ICH Q7/Q10, ISO/CEI 80079-34
  • Project Planning and Management
  • Risk assessment
  • Problem-solving
  • Quality Reporting
  • Continuous improvement
  • Ethnographic Research
  • Market Analysis
  • Reimbursement Analysis
  • New product development
  • Creo Parametric
  • Minitab, Sigma Plot, MATLAB
  • Microsoft Office, Power BI, SAP
Experience
Supplier Quality EngineerOct 2019 to Aug 2020
Company Name － City, State
  • Completed over twenty supplier quality assessments and mitigated the identified supply and quality risks.
  • Led multiple supplier continuous improvement projects and worked toward quality issue resolution using structured problem-solving methods.
  • Led two 6-month global improvement projects for the custom camLine QoS supplier management software.
  • Supported Quality inputs into four Life Science new product development projects.
  • Supplier Quality Power BI Superuser: represented the department in BI Quality Dashboard development and testing.
  • Managed multiple supplier-related changes, including the Change FMEA and V&Q process.
  • Conducted ten supplier statistical process control system reviews (PCS Reviews).
  • Developed a Life Science and Gamma Sterilization supplier assessment template and assessment criteria.
  • Assisted in the development of the ISO 80079-34 supplier assessment checklist which contributed to successful IECEx product certification.
  • Worked on the electronic certificate of analysis development and supplier enrollment.
Supplier Quality AnalystJan 2017 to Sep 2019
Company Name － City, State
  • Identified a number of functionality gaps in the camLine QoS supplier database and conducted an analysis of an alternative tool.
  • Worked directly with the software development to align system functionality with current supplier management processes.
  • Set-up, monitored, and summarized the results of the supplier risk assessment process to identify risk categories for all direct material suppliers.
  • Conducted on-site supplier quality system assessments, focusing on production raw materials.
  • Identified quality risks relevant to:Product and process control and non-conforming material.
  • Metrology system.
  • Supply continuity.
  • Verified compliance to Entegris Change Control expectations to identify risks related to product and process changes.
  • Targeted supplier risk reduction activities by identifying focus areas for continuous improvement and assigning appropriate gap closure activities.
  • Verified completion for 7 suppliers and their 58 identified gaps.
  • Reviewed over 300 low-risk supplier self-assessments to identify the presence or absence of basic quality system elements.
Global Supplier Quality AssociateJun 2016 to Jan 2017
Company Name － City, State
  • Conducted a gap analysis of the camLine QoS supplier database.
  • Addressed the identified gaps by adding all direct material suppliers, their company profiles, and plant information into the system.
  • Compiled and reported Supplier Expectation Survey data, supplier risk rating scores, and quality assessment outcomes.
  • The preceding drove the prioritization and planning of supplier quality assessments, supplier continuous improvement activities, and supplier risk mitigation activities.
  • Established monthly reporting and metrics format for supplier risk rating and quality assessment data to better suit Global Supply Management needs.
  • Initiated the self-assessment process for all low-risk suppliers to verify the presence of basic quality system Elements.
Anatomy and Physiology Teaching AssistantSep 2015 to May 2016
Company Name － City, State
  • Assisted Anatomy and Physiology students in their learning process and preparation for Anatomy and Physiology written and practical examination during the laboratory period.
  • Conducted tutoring sessions, prepared laboratory samples and managed room set-up for laboratory activities.
Education and Training
MSExpected in Aug 2021Georgia Institute Of Technology － City, State
B.S, Mechanical EngineeringExpected in 2022University of North Dakota
B.A., Biology2016Gustavus Adolphus College － City, State
Activities and Honors
  • American Association of University Women (AAUW) Selected Professions Fellow
  • Siemens Healthineers Innovation Think Tank at Georgia Tech: Certification & 1st place award
Certifications

• ISO 9001:2008 36-Hour Lead Auditor with Medical Device Focus (ISO 13485:2016) Training and Handwritten Examination. ASQ. Certificate Number: Q22252

• Certified Quality Technician. ASQ. Certificate Number: 24975

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Resume Overview

School Attended

  • Georgia Institute Of Technology
  • University of North Dakota
  • Gustavus Adolphus College

Job Titles Held:

  • Supplier Quality Engineer
  • Supplier Quality Analyst
  • Global Supplier Quality Associate
  • Anatomy and Physiology Teaching Assistant

Degrees

  • MS Expected in Aug 2021
    B.S , Mechanical Engineering Expected in 2022
    B.A. , Biology 2016

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