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I&I Quality Co-Op Resume Example

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I&I QUALITY CO-OP
Professional Summary

To obtain a full-time Quality Engineering position in the Medical Device Industry that will allow me to utilize my esteemed skills in analytical thinking, problem solving, mathematical aptitude, creativity, persistence, and ability to work closely with others.

Work History
Paragon Medical. Pierceton, INI&I Quality Co-Op | 01/2015 - 08/2015
  • Generated Control and Inspection Plans to be used during the manufacturing process of various instruments and implants, and edited plans as necessary.
  • Collaborated with numerous Quality Engineers to monitor the production of instruments and implants throughout all stages of the manufacturing process and addressed challenges as they arose.
  • Analyzed the stability of production processes through the use of Minitab Process Capability Tests and Gage Repeatability & Reproducibility testing.
Paragon Medical. Pierceton, INGlobal Design Center (GDC) Co-Op | 08/2015 - 12/2015
  • Generated Inspection Plans and First Article Inspection Plans for a line of surgical instruments during its Operational Qualification phase of design, and delegated the inspection to the proper inspectors.
  • Verified inspection data to ensure critical to quality dimensions were capable through the use of Minitab Process Capability testing, and investigated issues as necessary.
  • Drafted inspection protocols as well as Installation/Operational Qualification reports to close out various action items.
  • Conducted tolerance stack-up analysis activities in order to justify or verify new or current instrument designs.
  • Served as a scribe during multiple design validation cadaver labs as well as a lab assistant during customer implant and instrument cadaver labs as assistance was needed.
Paragon Medical. Pierceton, INI&I Quality Co-Op | 06/2016 - 08/2016
  • Collaborated with various NPI Engineers to produce Process Flow Plans, PFMEA's, Control and Inspection Plans for new instrument launches.
  • Analyzed data from initial product development runs in order to determine manufacturing capability of CTQ dimensions.
Paragon Medical. Pierceton, INQuality Engineer | 03/2017 - Current
  • Support Quality Engineering Department for sustaining business as the Quality Point of Contact for one of major customers.
  • Responsible for product released to full production and assist in transition of product from NPI to legacy.
  • Champion root cause investigations, containment, disposition of product, and corrective action implementation associated with customer initiated returned product or non-conformance complaints.
  • Support manufacturing floor operators and inspection department inspectors daily with decisions pertaining to quantifying conforming product as it moves through the defined process flow.
  • Create part specific inspection plans and perform updates as additional manufacturing or quality needs or specifications are identified.
  • Also implement changes in association with customer directed print updates.
  • Champion internal and customer initiated CAPA root cause investigations, corrective and preventative actions, and serve as Quality representative on Operation's driven CAR's / PAR's.
  • Complete and analyze GR&R and Capability studies using Minitab software for continuous monitoring of the stability of processes and implement more effective inspection methods when attempting to eliminate correlation issues between internal and customer inspection methods.
  • Use capability studies as a tool when attempting to reduce inspection frequencies.
  • Champion Supplier Change Requests and the associated required deliverables to seek customer approval for process improvements, implementation of new machines, and product transfers to other Paragon facilities.
  • Perform analysis of returned product complaints and internal quality hold cage non-conformances to identify trends and opportunities for improvement.
  • Lead Tiger Teams with operations and manufacturing counterparts to brainstorm corrections to the trends identified.
  • Create cosmetic criteria and inspection methodology work instruction documents to accompany various manufacturing and inspection process steps.
  • Edit and create process work instructions as improvements when warranted.
  • Aid in completion of customer MDR requests through the creation, updating, and collection of process flows, PFMEA's, contact materials, validations, FAI's, and inspection plans.
  • Support annual customer audits as directed by Quality Manager.
  • Interact with suppliers to identify root causes of quality issues and establish corrective actions for future orders.
  • Serve as the Quality Co-op supervisor responsible for interviewing and hiring new candidates and advising and assigning their tasks once hired.
Skills
  • RMA/ Non-Conformance Investigation
  • CAPA
  • MSA / GR&R
  • PFMEA
  • DOE
  • Supplier Change Requests
  • Problem Solving
  • Minitab
  • Visual Manufacturing ERP System
  • DocCompliance
  • Microsoft Office Suite
Education
Purdue UniversityWest Lafayette, INBachelors of Science: Biomedical Engineering
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Resume Overview

Companies Worked For:

  • Paragon Medical

School Attended

  • Purdue University

Job Titles Held:

  • I&I Quality Co-Op
  • Global Design Center (GDC) Co-Op
  • Quality Engineer

Degrees

  • Bachelors of Science : Biomedical Engineering

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