Quality Management Continuous Improvement

Deborah S. Smith

**** **** ***** ****, ****** MS 38651 - Mobile - 901-***-****

E-mail Address: ************@*****.***

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Experience Highlights

• Many years of experience in continuous improvement processes within the automotive and medical device manufacturing industries

• Worked within startup teams in the development of quality management systems as well as developed plans for plant closures

• Acquired Six Sigma Green Belt Certification through Cummins Engine Company

• Acquired Lead Auditor Certification to ISO 9001 / ISO 13485 Transition and maintain thorough knowledge and experience in auditing

• Have led multiple FDA inspections within the Medical Device Industry Education

BS, Manufacturing Engineering Technology, 12/91, Memphis State University, 3.0/4.0 Associate Degree, Mechanical Engineering Technology, 12/87, State Technical Institute of Memphis Six Sigma Greenbelt Certified Through Cummins Engine Company ISO 9001 Lead Auditor Certification

ISO 13485 Internal Auditor Transition Certification Work Experience

2020 – Present Director of Quality & Regulatory Affairs, Tegra Medical, Hernando, MS

• Lead a team of quality & regulatory professionals for all quality, regulatory, and quality engineering functions

• Lead the Environmental Health and Safety Team for maintaining a compliant system with continuous improvement efforts in maintaining certification to ISO 14001 & ISO 45001

• Actively representing the Hernando facility as the Management Representative

• Lead liaison with Notified Body/Registrar, FDA Inspections, Customer and Internal Audits

• Collaborate with team members from multi-sites consolidating quality management system procedures for the Division, Tegra Medical

• Develop metrics, analyze data, and lead the management review process

• Lead Validation Processes for equipment, special processes, and process qualifications assuring adherence to ISO and FDA quality standard requirements

• Actively represent Hernando for cross functional site auditing

• Lead Supplier Quality Auditing and monitoring

• Review Supplier Quality Agreements for regulatory, customer and company requirements 2015 – 2020 Quality Assurance Manager, Tegra Medical, Hernando, MS

• Managed Quality Engineering, Assurance, Regulatory and Quality Control function personnel

• Manage the Corrective Action/Preventive Action and Customer Return Systems

• Manage all Validations for Equipment, Software and Product Specific

• Perform Internal Audits of Quality Systems

• Assist during all FDA, ISO and Customer Audits and Perform cross site and supplier audits

• Develop Quality Systems and Revise Existing Systems to Assure Compliance to ISO, FDA, the EU MDR and new Regulations

• Developed quality presentation training materials and trained personnel at all levels of the organization

• Lead Continuous Improvement Efforts

• Manage Quality Functions for Design Transfer Activities and Participate in Internal Design For Manufacturing (DFM) Processes

• Implemented New Quality Management Software with the Initial Modules as CAPA, Document Control and Training for 4 Different Tegra Medical Locations

Deborah S. Smith

4581 Rose Marie Cove, Nesbit MS 38651 - Mobile - 901-***-**** E-mail Address: ************@*****.***

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2013 – 2015 Senior Quality Engineer Supervisor, Teleflex, Inc., Olive Branch, MS

• Supervised Quality Engineers and Quality Technicians

• Worked with Suppliers through Supplier Corrective Actions

• Worked with the Quality Team to Improve Quality Systems throughout the Facility

• Created and Maintain Inspection Plans within the SAP System

• Managed Quality Metrics for the Surgical/OEM/Medical Business

• Trained/Coached Employees through Quality System Improvements, Measuring Techniques, and Personal Development

• Lead Corrective Action and Preventive Action Process with cross functional and cross site collaboration

• Lead and Managed the Calibration System

2011 to 2013 Project Manager, Quality Engineering, Tegra Medical, Hernando MS

• Managed Quality Engineering and Technicians

• Managed Corrective Action/Customer Return Systems

• Developed New Quality Systems and Revise Existing Systems for Manufacturing Process

• Lead Quality Efforts for Multiple Design Transfer Activities with Customers

• Managed Gauge Repeatability and Reproducibility Activities

• Assisted in Leading ISO 13485, FDA and Customer Audits

• Train Internal Auditors

• Lead Internal Audits as one of the Lead Auditors for the facility

• Lead Improvement Projects

• Provide Classroom Training for Manufacturing Personnel

• Provide Quality Engineering Expertise and Mentorship to Quality/Project Engineers, Technicians, Auditors and Inspectors 2002 to 2010 Senior Project Engineer, Cummins Diesel ReCon, Memphis Plant

• Convert Products from Brokered to Reman for 4 Product Lines Maintaining Supercessions

• Provide Product and Quality Support for 4 Manufacturing Production Lines

• Introduce new Salvage Processes as Cost Savings – AC Core Creaming Project Yielded over 360K – AC Small Parts Projects Yielded over 65K

• Perform Competitive Analysis for Marketing’s Strategic Planning

• Work with Corporate in Qualifying New Suppliers for Cost Savings/Resource Constraints; Performing Endurance and Durability Testing, Validating Samples and Reporting Results

• Research and Qualify New Local Suppliers for Machining to Improve Delivery and Quality

• Support 6 Sigma Projects Company Wide – Con Rod Pieces Per Part Improvement, AC Shaft Yield Increase, Reman Con Rod Sales Increase (Patrick Wolfe Corporate)

• Manage Multiple Projects – 17% Warranty Reduction CHCAMM, AC Core Creaming, AD Core Creaming, Con Rod Quality Improvements, ETC. . . .

• Provide Necessary Support to BU Members, HPWO Teams, Marketing and Corporate 2000 to 2002 Divisional Quality Assurance Manager, Cole Vision Corp., Memphis Resident

• Managed 1 QA Engineer, 1 QA Team Leader and 4 QA associates in the Memphis facility-7 dotted line reports from the 7 Licensed Brand Sites

• Provided Quality Expertise and mentorship to 7 Technical Quality Facilitators at the different Licensed Brands Sites

• Transferred Frame Qualification Process for Licensed Brand Frames from Pearle to the Memphis facility

• Setup Quality procedures and flowcharts for all QA functions

• Assisted in Continual Improvement efforts and process control within the 7 Licensed Brand facilities

• Assisted in the implementation of ISO 9000 in several of the Licensed Brand facilities

• Managed multiple projects along with providing day to day support to the 7 Licensed Brand facilities Deborah S. Smith

4581 Rose Marie Cove, Nesbit MS 38651 - Mobile - 901-***-**** E-mail Address: ************@*****.***

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1995 to 1999 Commercial Quality Manager/ Process Quality Engineer General Electric Company, Memphis Lamp Plant

• Managed acquisition and shipment of materials, finished products and services for the Memphis facility

• Managed three-million-dollar inventory, 12 hourly employees, day rate and capacity planning

• Led the weekly production planning process with shop operations managers in the US and Mexico

• Reduced backorders $450,000 through 1998 year-end and another $100,000 through April 1999 as a Six Sigma Green Belt Project

• Worked with Transfer of Work Team Leaders to support Memphis plant closing in 1999

• Assisted the start up of two plants in Hungary, and the transfer of work to a stateside facility, ahead of schedule without service interruption

• Developed and implemented a quality system to meet QS 9000 requirements through certification

• Assisted 3 additional facilities in achieving QS 9000 certification

• Led the Memphis facility through two successful surveillance audits

• Managed a quality system including documentation, calibration, internal auditing, corrective and preventative actions, a production part approval process and quality records system

• Developed and implemented process flow diagrams for all product lines throughout the plant and conducted plant wide training for three shifts. Was selected as the Beta site for the GE Lighting Master Documentation Control System 1993 to 1995 Quality Engineer, Wright Medical Technology, Inc. Arlington, TN

• Developed quality improvements through gage design, acquisition and setup, and precise instructions

• Developed system level procedures and customer complaint analysis for Femoral Implants and Instruments

• Led cost reduction projects and reduced final inspection by 50% savings over $109,000 per year 1985 to 1993 Quality Assurance Engineer, Diesel ReCon Company, Memphis, TN

• Supported new product introductions including Process Failure Mode Effects Analysis, and Design of Experiments.

• Assisted Manufacturing Managers to setup and analyze results using Statistical Process Controls and process improvements

• Developed Vendor Certification Program

• Developed Inspection plans for 4 product lines

• Worked with cross functional teams to maintain products from disassembly, remanufacturing, clean, package and shipping

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