Quality Engineer Engineering

Francis Ugoeke

*** ******* ****. ******, ** ***** • 919-***-**** • adcids@r.postjobfree.com

PROFESSIONAL PROFILE

Accomplished Quality Engineer and a recent Master of Science in Engineering graduate with over three years of experience providing Quality Assurance services to major corporations. Experience includes:

• Used Statistical Process Control (SPC) method to monitor and control test results from OQ and PQ validation stages. Utilized Minitab to identify CPK, PPK, and Normality range of collected data results, and implemented a corrective action on occasions where numbers were out of range due to special cause variation.

• Developed standards and methods for inspection, testing, and evaluation by obtaining requirements and the defect library from customers, which included classifying defects into critical, major, and cosmetic, creating visual defect reference documentation for inspectors, creating sampling plans using ANSI standard and appropriate AQL, and conducting visual inspections at Quality Control stations, utilizing CMM and CT scanners for FAI.

• Devised sampling procedures, designed and developed forms and instructions for recording, evaluated and reported quality and reliability data, created CAPA’s on failed processes and procedures and used best practices and processes to implement lean manufacturing processes.

• Created sampling plans using Minitab and ANSI table; utilized Minitab to generate the OC curve and appropriate sample size based on Lot Size and Confidence interval and reliability set, and used CMM data to present to the customer the appropriate capability and summary reports highlighting the dimensional acceptance criteria set.

• Created an MRB process for determining the disposition of non-conforming (discrepant) material and associated corrective actions, which included deciding the appropriate disposition action, issuing a material Review Action

(MRA), and creating an NCMR tracking matrix to track the status of non-conforming items.

• Trained Quality Inspectors, Quality Techs, and cross-trained Quality Engineers on all the quality processes, which included training teams on all stages of validation and maintenance of appropriate training records.

• Wrote numerous level-3 standard operating procedures, standard work instructions, flow charts, and reference level-4 forms, maintaining the most current revisions in a QMS document system. EDUCATION

North Carolina State University, Raleigh, NC 2019

Master of Science: Integrated Manufacturing Systems Engineering GPA: 3.7 University of North Carolina A&T, Greensboro, NC 2010 Bachelor of Engineering – Electrical Engineering

TECHNICAL SKILLS

Manufacturing processes: Process Enhancement & Standards, Productivity Optimization, Quality Control & Quality Assurance, Cross-Functional Collaboration, New Product Launches, Focused Decision-Making, kaizen, PFMEA, Poka-Yoke

Quality Standards/ Regulations: ISO 9001, 13485, FDA 21 CFR Part 820, 11, 803, 806 & 810, CGMP Lean Six Sigma: DMAIC, Root Cause Analysis, DoE, CAPA, 8D Design and Analysis Software: AutoCAD, Microsoft Office, Visio, Excel: VBA and Macros, Minitab, SQL, SAP Statistics Tools: Pareto, Histogram, Fishbone, Quality Chart, Control Charts, Scatter Chart, Flow Chart.

CERTIFICATIONS

Internal Auditor for ISO 13485:2016, Certifier: BSI Group Sep 2019 Lean Six Sigma Green Belt Certification: Institute of Industrial and Systems Engineers (IISE) Apr 2014 PROFESSIONAL EXPERIENCE

Flex, West Columbia, SC – Quality Engineer May 2019 – Present

• Wrote standard operating procedures, standard work instructions, and flow charts; maintained ISO 9001, ISO 13485 compliance documents, and writing control documents.

• Review and edit quality documents before they are released as a new revision in the QMS.

• Verify the effectiveness of corrective actions when closing out major ISO 9001 non-conformances and coordinated non-conforming materials for the Material Review Board.

• Perform Process FMEA on NPI and led cross-functional teams through continuous improvement activities.

• Wrote TMV protocols and TMR’s, Conducted CAPA’s and Gage R&R on processes and equipment. Francis Ugoeke Page 2

• Train Quality techs and Quality inspectors across the manufacturing processes, installing a “can do” attitude.

• Support and facilitated root-cause investigations, corrective actions, preventative actions, 8D, and rapid improvements in events.

• Participate in multiple regulatory audits; In-process Quality Control subject matter expert.

• Represent the quality department for Customer Focused Team meetings. Dell – EMC, Apex, NC – Quality Assurance (Contractor) Sep 2018 – May 2019

• Completed GMO regulatory compliance and product audit inspections on enterprise storage systems, i.e., Isilon, Unity, Data Domain, Avamar, Dell switches and servers using SAP, Just Q, Gemstone, and GPS run sheets.

• Drove Erasure Auditing – Collected erasure test logs and compared serial data to archived files to ensure the erasure process was completed.

• Identified issues that led to CARs (Corrective Action Requests) and OFIs (Opportunities for Improvement).

• Alerted engineering and operations to conditions that adversely impacted the customer experience.

• Lead a defect reduction team resulting in a 20% increase in quality first pass yield Asteelflash USA Corp, Morrisville, NC – Quality Engineer Tech/ QC Supervisor Sep 2018 – May 2019

• Supervised eight full-time Quality Inspectors responsible for the inspection, documentation of batch records and provided training/assistance.

• Conduct daily team tier meetings that focuses on safety, achieving KPI’s, accountability for Gemba owners in the processes.

• Introduced short and long-term proposals to reduce waste and increase daily production.

• Drafted and helped published three process quality instructions that set the standard for ideal machine operation.

• Performed final QA on products, ensuring accurate inspection and timely completion of inspection requirements.

• Measured and analyzed quality standards and ensured compliance on every stage of the process.

• Completed Complaint Evaluations which includes review of Batch Record documentation, evaluation of produced samples, and performance of root cause analysis for manufacturing and packaging-related customer complaints.

Volvo Group Mack Truck Operations, Macungie, PA – Industrial Engineer Co-op Jan 2018 – Sep 2018 Quality Engineer Intern (Jan 2018 – May 2018)

• Performed a management project relating to torques and product safety for product Class-28 and Class-29.

• Created an audit template that categorized torques based on production sub-line following special characteristics management principles. Audited all stations accordingly and prepared an action plan based on the findings with responsible teams.

• Created an audit issues file with Excel MACROS, which automated charts generated from the QULIS case handling forum.

• Prepared a Quality process flow model for finding loopholes and aligning the sub-departmental KPI/objectives using the IDEFO tool.

Manufacturing/ Maintenance Co-op (May 2018- Sep 2018)

• Supported the Manufacturing Engineering department on the Chassis Insourcing project to completion.

• Analyzed root-causes affecting the timely delivery of parts, increased the First Time Through (FTT) rate by 8%.

• Analyzed ERP data to determine the batch/hardware parts that needed new locations at Point of Use due to production rate change.

• Audited storage locations to determine and kill ghost packages to match the physical inventory with the ERP system.

• Reduced the engine assembly process time by 40% using DMAIC.

• Increased production by 20% by organizing and leading a daily prime meeting, at which several production issues were discussed in-depth, severity points assigned, solutions assessed, and the follow-up team assigned. Michelin Tire and Rubber Company, Asheboro, NC – Industrial Engineer May 2017 – Aug 2017

• Assisted in industrial engineering activities for the introduction of new programs into operations using best practices and processes to implement lean manufacturing processes.

• Balanced the loads on shipping, extrusion, and finishing forklift drivers to ensure no driver was loaded over 85%.

• Acted as a medium between the Union Engineers and Industrial Engineers.

• Fully engaged with and supported the culture of continuous improvement throughout the plant. BMW Manufacturing, Geer, SC – Value Added Production System (VPS)/ISE Co-op Aug 2016 – May 2017

• Supported management initiatives, including workshop development and implementation.

• Facilitated the growth of the VPS by meaningfully contributing to the workshop and overall outfit.

• Successfully completed the G01 line balancing before the projected time; Performed Standard Time studies. Francis Ugoeke Page 3

• Promoted lean manufacturing operations with 5S, Poke Yoke, Kaizen, Kanban, TPM, SMED and other initiatives, to continuously improve processes

• Maintained and audited productivity data to assure efficiency and utilization of manpower per labor standards.

• Assisted with the creation and introduction of the mobile training Kiosk for the two manufacturing buildings. Goodyear Tire and Rubber Company, Fayetteville, NC – Industrial Engineer Intern May 2016 – Aug 2016

• Collected and analyzed time data for several VMI machines and processes and recommended improved total process time. (Changed the VMI machines standard production/processing time from 1m to 47secs)

• Successfully computed and regularly updated the company’s production OEE.

• Identified the time required to complete specified tasks and outlined and analyzed time data for process improvement efficiency.

• Performed standard Time Studies and line balancing on several production processes and reported findings in a professional presentation.

Corning Cable, Winston Salem, NC – Quality Associate, Line Operations (Contractor) Oct 2014 – Jan 2016

• Conducted random sample inspections on finished goods before they are shipped out to customers.

• Created visual aids on process flows for standardization and consistency for six sigma projects and ISO 9001 projects.

• Conducted time studies on work flow that assisted in identification of bottlenecks and inefficiencies; Presented and documented findings to management team.

• Utilized Six Sigma and industrial engineering principles for quality enhancements.

• Lead on root cause data analysis for commonly recurring complaint classes.

• Introduced the zero-defect culture on multiple production lines. Bonset America Corporation, Brown Summit, NC – Quality Assurance Tech. (Contractor) Aug 2010 – Oct 2014

• Performed In-process Quality inspections following AQL sampling guideline.

• Provided Quality Assurance Line Operations oversight for multiple manufacturing lines and packaging areas.

• Created an electronic visual board to view and track status of projects, exceptions and department statistical metrics.

• Lead a kaizen that resulted in 10% improvement in cycle time and elimination of unnecessary movement of operators.

• Collaborated with customer quality and engineering team to reviewed/update standard operating procedures, standard work instructions and flow charts.

• Presented proposed process changes and quality issues to the management team.

• Identified areas of potential improvements and implemented approved changes.

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