Michael L. Caldwell

*** ***** **** *****: 901-***-****; 901-***-****

Collierville, TN 38017 Email: acvll3@r.postjobfree.com

Leadership Profile

I am a proven leader with outstanding results in lean engineering, quality management, quality engineering, project manager and operations management

Empowering change leader skilled in operation management, team building and initiatives that align organizational capability and drive improvements to optimize potential and achieve business goals.

Highly experienced leader with solid history of leading cross functional teams to new levels of success in highly competitive industries and fast-paced environments.

Pragmatic leader with proven ability to successfully analyze an organization’s critical business requirements, identify deficiencies and develop innovative and cost-effective solutions.

Energetic, Customer focused, results-driven Business Partner with solid history of successful “Turnarounds”, Start-ups, and Lean/Cost savings initiatives.

Areas of Expertise

Operation Management ISO/cGMP/FDA/AIB Compliance Lean/Six Sigma Methodology Start-up Operations Quality Systems Supplier Quality Management Packaging and Sustainability Project Management DuPont Stop Change Management Customer Relationship Management ROI Measurement Performance Metrics Management Continuous Improvement Techniques Statistical Analysis PPAP/FMEA Vision Systems Kaizen

Professional Experience

ZIMMER-SPINE [CONTRACT}-MEMPHIS, TN March 2016 PRESENT

SR.QUALITY ENGINEER

Perform quality review of design and development of Class II medical devices.

Coordinate design review meetings to review all quality aspects of new products. Interface with Product Development to ensure quality considerations during the concept stage.

Lead the review of complaints and development of the risk management plan and risk analysis.

Develop overall quality plan for new product implementation (including product acquisitions/transfers) including inspection, test, and audit procedures. Identify areas requiring reliability testing.

Develop inspection techniques and procedures to ensure product integrity and compliance with design specifications.

Responsible for the writing, approval, and implementation of inspection procedures and operator self-inspection procedures.

Provide employee training programs in Quality Control and Manufacturing.

Develop custom gage designs, GD & T and gauging methods.

Work with suppliers, management, Engineering and Manufacturing associates in the resolution of quality problems and to implement continuous quality improvement programs including: design of experiments to identify and thus control process variables; review of process audit/validation activities; and installation of statistical and non-statistical process control.

Perform statistical analysis of designs using Minitab and Sigma XL.

Interface with Manufacturing Engineers to review processes for new products and coordinate process validations and capability studies. [IQ,OQ,PQ]

Work with Product Introduction Teams to recommend process monitoring devices where applicable.

Manage activities within the quality engineering area related to non-conforming material, CAPA, complaints investigation, problem solving, trending, Implement quality management system and ensure functional compliance to the applicable FDAs 21 CFR 820 design control requirements, GMPs, international standards and state requirements. Participate in internal audits conducted by internal employees and regulatory agencies.

NIKE-Flex [contract]-Memphis, TN March 2015- June 2015

QUALITY ENGINEER – QUALITY MANAGER

Developed new quality control measures and practices for the manufacturing printing process of customized socks and sport shoes.

Successful results from FMEA, and PFMEA, Gage R & R, implementation of key control measures

Implemented statistical process control measures at critical points of the customization process

Developed key measurable defect areas for process improvements measures

Stellar results from Gage R&R studies on process capability

Lead and supervised 8 quality technicians and 2 salary employees through training standardized matrix

Medtronic Inc., Memphis, TN 2012 – 2014

Project Engineer-- MANAGER

Project engineer for the (AMET) Concurrent Engineering Group of the Global Operations Division. Tested and validated vision recognition systems for manufacturing medical devices. Wrote system requirements and factory acceptance testing documentation.

Lead the project on the construction and infrastructure of the Process Development Center (PDC) and the development of a metrology lab, which included contractors, sub-contractors and 5 employee team members

Implemented new technology-vision systems, dimensional stability systems, RFID read systems and tags, utilizing cross-functional skill sets. Conducted validations in accordance with OQ, IQ, PQ protocol

Successfully developed the integration of RFID-UDI optimization projects to meet FDA and ISO requirements

Maintain an effect budget, forecast and man power requirements.

ThyssenKrupp Elevator Manufacturing, Memphis, TN 2006 – 2012

Test Engineer Lab MANAGER

Engineer credited with analyzing and improving test processes and operations. Tested software on elevator control systems and circuit boards, supporting both hydraulic and electrically driven elevators. Qualified and validated new components. Wrote test plans and procedures to develop standards and set up calibration. Supported all engineering functions within electrical and mechanical development.

Coached and motivated a team of engineers in safety, quality, continuous improvement, Thermotran and other lab equipment. Designed two laboratories projects for software and hardware applications.

Lead projects on the construction of elevator controller simulators interfacing full electrical elevator operations, signal fixtures, motor controls, and AC/DC motor applications

Created new product performance reliability tests, designing and debugging elevator control systems, fixtures and methods for testing components

Accomplishment: Key developer in the qualification process of replacement components on over 265 boards.

United States Army (Civil Affairs), Baghdad, IR 2007 – 2008

Provisional Reconstruction Team Chief

Responsible for presenting slide briefings of all accounts and projects to various authorities, including the commander of the Multi-National Force, Special Operation Command, US Embassy and US Aid Officials in the Green Zone.

Lead projects with the collaboration of provincial governments in the areas of education, law enforcement and agriculture

Supervised personnel in the rebuilding of local schools, government infrastructure, and tribal meeting facilities .

While maintaining a 30 million dollar budget

Purchased equipment, vehicles and weapons for the Iraqi Police Force in excess of 30M dollars

Supervised a 13-man special operations unit.

Flextronics, Memphis, TN 2002 – 2006

Process/ Test Engineer

Engineer tasked with integrating new wireless modern products and validating software for wireless modems. Programmed external and internal models using Sierra Wireless based software.

Supervised 30 technicians and engineering support employees for the start up of Apple laptop repair service

Established process line for 30 million dollar account (Nortel), securing infrastructure for the Nortel fast forward logistical operation

Designed test processes for Apple laptop systems project

Accomplishment: Developed process improvements that resulted in a very profitable margin.

GIL Technologies, Collierville, TN 1992 – 2001

Technical Coordinator /Quality Supervisor– Research & Development Supervisor

Coordinator charged with performing product analysis on high frequency materials, developed software for production analysis and establishing product-testing procedures. Implemented Underwriters Laboratories Analysis, collected data and provided variance notification on substandard products. Proven record in negotiating pricing and contracts for equipment purchases. Business closed operations in June of 2001.

Successfully lead 10 quality inspectors, 3 lab technicians and 2 process engineers

Improved directional warp on circuit boards, leading to minimized warp level, improved dielectric constant thermal properties and enhanced flame retardant levels achieving UL certification

Completed complex quality assurance and control testing and analysis, repairs and reliability testing

Performed precision adjustments and setup of sensitive equipment, paying close attention to component variance

Accomplishment: Developed 6 research projects-on 1. laminate processes, 2. additives, 3. builds, 4. test methods, 5. dielectric constant design within circuit boards and 6. use of di-vinyl benzene in circuit board manufacturing-all leading to US patent filings

Accomplishment: Increased quality standards by 85% through initiating methods determining the sufficient amount of flame retardant in high frequency circuit boards

Supervisor responsible for leading 20-member team in achieving daily quality assurance standards and significantly improving various programs, including the Total Quality Management Program, the Customer Complaint & Corrective Action Program and an Inspection Lab for incoming raw materials. Performed quality assurance and control, reliability testing, analysis, assembly and repairs

Developed and implemented Internal Auditing Procedures for ISO 9002 Certification Process

Established quality programs, developed effective curriculums enhancing employees’ knowledge base

Accomplishment: Spearheaded inspection programs, which led to a 75%, increase in overall product quality and resulted in a 250K increase in revenue

Education & Training

Master of Science, Engineering Management, Christian Brothers University, Memphis, TN

Bachelor of Science, Business Administration, University of Mississippi, Oxford, MS

Bachelor of Science, General Engineering, United States Military Academy, West Point, NY

Awards & Military Distinctions

United States Army Reserves (1990-2009) Field Artillery: Special Operations, Civil Affairs, United States Army (1980-1990) Bronze Star for Valor – 2nd Award Army Commendation Medal – 4th Award Iraq Campaign Medal – 2 Stars Army Achievement Medal 3rd Award Overseas Service Ribbon 4th Combat Action Badge Parachute Badge Air Assault Badge

Leadership Profile Additional

WMS, Red Prairie

Project Management, [PMP}

CSSGB Six Sigma Green Belt

Embedded Software

Lean Manufacturing

Black belt

Budgets/Cost/Manning

FMEA, PFMEA, Gage R & R

Six Sigma, TQM, SPC, 5S

Quality Systems –Sourcing

RFID and ESD Packaging Application

EHS Applications

FDA, ISO/T9000 Standards Medical devices and instruments

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