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Manufacturing Quality Engineer

Tampa, Florida, United States
August 15, 2018

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Michael Quade Flanders

Tampa, Florida 864-***-****


Medical and Electronic Manufacturing

Uses DMAIC methodology to identify and correct quality and manufacturing deficiencies. Determines root causes and corrective actions using multiple problem-solving techniques. Conducts failure analysis and creates detailed reports for internal and external presentation.

Highly versatile experience with a broad knowledge base. Experience in mechanical and electrical systems and the interactions of each component. Excels at working in multi-disciplinary teams to achieve results. Strengths include:

CAPA process

Customer Quality Requirements

Failure Analysis

21 CFR Part 820


Six Sigma/8D/KT Methodology

Process Improvement

Component Drawings and Specifications


(ALKU) Cardinal HealthCare- Augusta, Georgia 2017-present

Quality Engineer (Complaint/Validation Remediation) –Contract

Completed 120 complaints in two months

Performed audits of equipment validations. Provided summaries of status and remediation plan. Worked with company to implement remediation as necessary for compliance.

Reviewed and updated Approved Supplier List. Obtained required supplier documentation.

CONMED CORPORATION – Largo, Florida 2008 – 2016

Medical Device Manufacturer for Orthopedic surgeries

Quality Engineer-Shaver Blades, Molding, SRO, Electro-Mechanical Assemblies

Reviewed validations, verifications and engineering changes for products and processes to ensure compliance with FDA requirements. Conducted Root Cause Investigations using 8D, 5 Why and other Quality tools. Dispositioned non-conforming product based on risk analysis and business needs.

Created process to address component failures at global Service and Repair facilities. Uncovered programming issue with equipment for motors sent to International Service and Repair facilities. Replaced motor programming equipment and implemented post-program check.

Created and implemented new report process for quality metrics reporting to identify non-conformances and opportunities to reduce waste.

Eliminated potentially harmful manufacturing defect through Root Cause Investigation and Corrective Action. Re-engineered tooling to correct process.

Created facility wide cosmetic standard to use as pass/fail criteria for cosmetic defects with devices that prevented unnecessary manufacturing delays as well as unnecessary scrap.

Eliminated field performance defect with pneumatic hoses through Root Cause Investigation and Corrective Action. Hoses did not perform properly upon incoming customer testing. Through testing of the product, root cause was determined to be a change in material by supplier.

JABIL CIRCUIT – St. Petersburg, Florida 2005 – 2008

Contract Manufacturer of Circuit Boards

Quality Engineer

Implemented, maintained and improved quality on specific product families. Provided weekly quality performance reports to customers. Worked with cross-functional teams to implement new products.

Increased End-to-End yields by an average of 5% by modifying various processes.



Increased yields on specific group of assemblies by over 5% at In-Circuit Testing by modifying various processes.

Managed new customer and implemented processes to bring new products to market.

KEMET ELECTRONICS, Simpsonville, South Carolina 2000 – 2005

Largest Manufacturer of Solid Tantalum Capacitors supplying Commercial, Automotive and Military circuit board manufacturers and OEMs.

Staff Engineer (2004 – 2005)

Served as Liaison for four manufacturing plants both domestic and international. Reviewed process flow for current and new product. Implemented, maintained and improved quality on high end products used in military and medical applications. Used Minitab for DOE, T-tests, ANOVA and I-MR charts as quality tools to monitor quality and implement improvement projects.

Created and implemented two process improvement projects which increased yields on two specific part types by over 20% through DOE and statistical analysis.

Initiated on-site plant start-up to assist other manufacturing plant in meeting customer demand. Evaluated equipment to ensure functionality. Manufactured and reviewed first production of product lines to ensure consistent quality between plants.

Developed manufacturing processes for new part types which allowed release and sale of part types.

Customer Quality Engineer (2002 – 2004)

Resolved customer quality issues with electrical and physical defects using 8D methodology to determine root cause and appropriate corrective actions. Conducted internal audits to confirm implementation and effectiveness of corrective actions.

Based on process engineering experience, chosen to assist in manufacturing projects for various product lines, including the Aluminum Organic Capacitor line.

Established the use of alternate materials through Quality Assurance testing such as: SMT, Thermal Shock and Load Humidity.

Process Engineer (2000 – 2002)

Monitored quality and implemented process improvements for product lines. Used SEM analysis for electrical failures to determine possible manufacturing defects. Analyzed product quality using tollgate measures and Quality Assurance testing such as: Weibull Life Testing, Temperature Stability and Surge Stress Step Testing.

Increased overall yield of product line by 10% by adjusting multiple process steps and performing Designs of Experiments to achieve the optimum process settings.

Established the use of alternate process steps to reduce manufacturing costs by creating a more robust product and reducing electrical failures at end of line testing.


Bachelor of Science (BS), Ceramic Engineering, Clemson University – Clemson, South Carolina



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