Identifies, develops, and manages process improvement projects specifically aimed at improving operational efficiencies (waste, productivity, costs). This includes the ongoing development and training of required methods and procedures. Trouble Shoots daily production and process problems, communicates with Sr. Manufacturing Manager, Production Superintendent, Supervisors and Operators regarding run problems, investigates root causes and recommends and implements corrective actions.Works in conjunction with manufacturing and maintenance personnel to ensure consistent operation of equipment to prescribed conditions, once developed. Identifies any/all of the following: set-up and run parameters; maintenance intervals; and/or material specifications. Develops supporting set up, run and change over documentation and facilitates all training.Writes, performs, analyzes, and reports on validations to support process standardization.Develops project justifications, ROI analysis and proper project/capital requests consistent with company policy. Takes lead on management and implementation of safety initiatives. Always operates with safety considerations as paramount.Assists Manufacturing in preparing standard operating conditions with the appropriate input from the machine operators, supervisors and technical personnel.Determines the need for and justifies capital projects such as source equipment and components by completing and routing Allocation for capital form.Acquires knowledge of procedures, work instructions, and associated forms as required by the Supervisor.Other duties as assigned.Assist in ensuring HACCP, GMP’s Work Instructions, and safe quality food system requirements are in compliance

Help roll out an operational strategy in line with company business strategy;achieve the operational objectives (e.g. quality, productivity profitability, maintenance, etc.);implement standardized manufacturing practice, optimization and development of manufacturing processes in addition to implementing equipment management best practices;Ensure technical support and share best practices;Assist with commissioning new equipment, tests carried out by the unit and support investment projects Deliver on technical innovation objectives and keep a watch on new technologies and share them within the organization/ Support the team in the preventive and predictive maintenance. responsible for establishing and reviewing process controls, emphasizing customer satisfaction, continuous improvement, and waste reduction. Providing measurement systems and inspection techniques that are developed and maintained to advance department goals and objectives in support of plant goals and objectives as monitored and reported through KPI. Plans and directs all quality related functions in the plant. Daily provide leadership and direction to Quality Supervisor and associates within the plant for the overall development and administration of Quality resources within the plant.

Manage the monitoring, measurement, and review of internal processes, especially those that affect the quality of the organization’s products.Lead a team of Quality techniciansReport to top management on the performance of the QMS (e.g., results of quality audits, corrective actions), including the need for improvement.Conduct weekly internal audits of finished product.Put in place standard work in all phases of the plant.Conduct monthly training to quality standards.Responsible for accuracy and timely inspection/calibration of monitoring and measuring devices.Keep up on standards, regulations/laws, issues, and news with respect to product (service) quality.Actively participate in production meetings with the manufacturing team

Coordinating and supervising all Quality Assurance activities in Production and in Laboratory to assure exceptional quality product is delivered to the customerEnsuring Production Process output is in compliance with customer expectationsBeing responsible for quality related communication with customersEnsuring production compliance with all internal and customer bottle and packaging specificationsMeasurements and Testing: measuring recording and reporting dimensional, functional and visual attributes per internally specified requirementsmaintaining optimum performance and internal calibration checks on quality related equipment scheduling calibration of equipment requiring outside calibrationmaintaining measurement database integrityCustomer Relationship Management regarding Quality issues: working with production and customer to determine optimized process settings to assure specified requirements are met (specifically during sampling and product qualification process) hosting periodic customer visits, managing customer complaint processSupport plant to ensure compliance with all ISO 9001:2015 quality management system, FSSC 22000 food safety management system, and other standards & regulations.

• ISO 9001:2015 certified lead auditor leading plant certification in new standard. ISO 9001:2015• Work with OEM customers on quality issues maintaining the quality customer data base.• Oversee the supplier PPAP and PSW process working with engineers, buyers, and planners to meet customer requirements. • Provide PPAPs to customers (PFMEA, Control Plans, Design Record, Drawing, and Measurement Report). • Provide training to the Quality Techs on GD&T using gages, calipers, and micrometers.• Work with the CMM supervisor on incoming FA (first article) testing for PPAP’s.• Initiate action to correct and prevent the occurrence for any nonconformities relating to product, process and quality system to protect the customer.• Lead or support teams in applying the 8D and or six sigma DMAIC methodology to eliminate waste and provide documentations to customer for Corrective actions and Preventive actions complaints.• Maintain and conduct daily meetings at the quality SQDIP (Safety, Quality, Delivery, Inventory, and Productivity) boards.• Actively meeting two times a week to review MRB nonconforming material. • React to assembly lines quality needs with 7 direct reports over 6 assembly lines.

Lean Knowledge: DMAIC; Standard Work; Kanban / Pull Systems; TPM; Kaizen; Problem Solving ; 5S; Value Stream Mapping; Continuous Flow / Cell DesignProvide SOW’s (Statement of Work) for new capital equipment. Work with site controller to manage plant budget. Site annual revenue was 55M. Lead and train 250 employees what the 6S program is and insuring follow-up on open items has been completed.Assigned as a Safety Officer to support the ISO 14001 certification conducting Gemba walks and reporting to the EH&S manager any findings.Oversee a 2.5M dollars in productivity projects each year that add to the bottom line of the overall 4 wall cost in savings.Responsible introducing the plant to OEE (Overall Equipment Effectiveness), reported out monthly to corporate. Lead all training for Lean Six Sigma and oversee Kaizen and SMED Events for Cheraw plant. Keep a “pulse” on plant-wide activity maintain a yearly list of Kaizen events and schedules.Worked as the interim Quality Manager until a new manger was hired.Grained corporate recognition for conducting a Lean Event in the screwdriver assembly area that resulted in $150,000 dollar savings, I was able to increase productivity by 40% eliminated the waste in the department get materials to point of use, reduced inventory, and put in place FIFO system using the Toyota’s 4P methodology. Free up 1,600 sqft. by new layout of the department. Actively monitors industry trends, equipment and process innovations, and emerging technologies and creates initiatives to capitalize on new opportunities.Ensures that change management structure and proper resource allocation is in place to implement seamless process/product change, continuous improvement activity and/or new product introductions.Manage Lean/Kaizen processes to integrate Kaizen and 6S philosophy in operations culture.

Responsible for plant infrastructure, Hazmat, Maintenance, R&D, and Quality Control with three direct reports R&D Manager, Quality Manager, and Maintenance Supervisor. Responsible for the plants ISO 13485 medical quality system, ISO 9001, and Regulatory Affairs.Lead all R&D function, conducting weekly meetings with sales and owners to report the current state of all open R&D projects. Conduct continuous improvement projects throughout the operation using lean methods identifying and eliminating the 7 waste Transportation, Inventory, Motion, Waiting, Overproduction, Over Processing, and Defects. Conducting Kaizen events along with training employee's in using the LEAN tools.

MEDICAL COMPRESSION GARMENTS Presented quality metrics power point at the monthly Quality Council Meetings. Management Review Board.Oversaw and implemented from the ground up a QMS, ISO 13485:2003 at the corporate office in Kansas City and the division in Ellerbe NC to be in compliance with FDA 21 CFR 820.Traveled internationally to Italy to approve equipment before shipping to the plant.Conducted IQ, OQ, PQ validation on new equipment.Worked with customers on justification of returns and credits.Traveled to corporate office and conducted training on Internal ISO auditing and also the fundamentals of ISO 13485:2003 regarding the Class I and Class II medical devices.Led the company through two FDA site audits. The last audit resulted in no warning letters.Led the plant in lean efforts to reduce waste and increase throughput, working with department supervisor.Led plant preparation coordination of internal and external audits/inspections.Worked with plant and business leadership to change the culture to LEAN thinking. Planned and submitted budget for Quality, Production, and Purchasing Departments annually.Routinely interacted with the Plant Leadership team to help maintain a balanced perspective on improvement priorities and the impact of changes on plants and the division as a wholeFunctioned as the plant's Quality Management Representative for the FDA and 3rd party auditors.Developed policies and procedures that affect operational and compliance status and involving the appropriate functional groups in communications and decision making.Provided strong leadership in design review, development and implementation along with risk analysis. Led six sigma projects on the production floor. Use Mini-Tab for data mining. Addressed product issues, ensuring involvement of appropriate functional groups in communications, developing consensus, and decision making.Provided direction in the implementation of effective corrective and preventive actions

Managed quality assurance laboratory and Military contracts working directly Natick on new products. Worked with engineer to developed fabrics new to the military.Wrote justification for new equipment in laboratory. Worked directly with customers on processes that meet strict customer specifications and industry standards including requirements for AATCC/ASTM/MIL SPEC.Traveled internationally to resolve customer quality issues.Maintained measurement equipment control methods, such as calibration, maintenance, and Gage R&R. Used Quality statistical methods and compiling trend charts to bring visibility to product properties that may not meet the internal specs. Provided training and development to quality technicians.Worked with purchasing to maintain partnerships with yarn and fabric suppliers. Worked with sales and customer service to issue credits and returns. Wrote and maintained product specification and military documentation requirements. Provided customers NAFTA and CAFTA certification. Optimized test procedures to improve efficiency whenever possible.Utilized continuous improvement tools, etc. lean, 5S, value stream mapping flow, and Kaizen. Provided sales with leads for military contacts. Was point person for all military testing, plan, and submitting, Established quality audit sampling plan of finished goods. Set –up new process for sample cutting in the laboratory to increase accuracy of testing and repeatability.

PTFE MEMBRANE, LAMINATION, NON-WOVEN AND WOVENS.Played a key roll in the develpment of ISO9001:2000 QMS for the Ivyland plant certification.Work directly with suppliers to eliminate root causes for Nonconformance’s, reviewed metric reports with suppliers.Manage Strategic Supplier data base and program. Donaldson Ivyland Ship to Product manager. Insure materials meet specification for JIT (Just in Time) production schedules.Develop methods and procedures for vendors. Reporting requirements, concession request, etc…Work with buyers and planners to ensure availability of raw materials. Was trained and conducted LEAN events (Value Stream Mapping, 5S, Kaizen, and SMED)Support product development on new/existing material specifications and sources.Travel 25% to suppliers and outside processes (OSP) to resolve issues as well as verify adequate controls are in place to minimize risk to Donaldson Company, Inc. by conducting site audits.6 sigma core team member, worked under the direction of onsite black belt. Active member of the Supply Chain Improvement Team to reduce waste and understand what our customer values. Work with suppliers to resolve testing discrepancies- verify supplier testing practices match those of Donaldson Company, Inc.

I was the 1979 inter-service Welterweight Boxing Champ