GERALD J. EVERETT

**** ***** **** **** **** Phone: 801-***-****

Layton, Utah 84040 aczgvk@r.postjobfree.com CELL Phone: 801-***-****

OBJECTIVE: To utilize my excellent Customer Service, Engineering, Quality Systems and Interpersonal skills for the growth and development of your company and the associated service organization within the facility for higher profits, increased quality, ultimate customer and management satisfaction.

EDUCATION: Bachelor of Science, Industrial Engineering w/Quality Engineering, Weber State University.

Masters in Engineering Administration from the University of Utah and

The Management Certificate Program from the University of Utah

Certified by IBM and Storage Technology in Statistical Process Control and Six Sigma Quality Systems.

Lean Manufacturing Practices, 5S, KanBan, Kaizens.

Certified in MOST and Computer MOST a time measurement system.

Certified in current Good Manufacturing Practices “cGMP”, both Auditing, Training and Labeling

21 CFR Parts 110, 111 and 221 Food, Dietary Supplements and Pharmaceuticals

Training in ISO standards – specifically 1101, 2859, 9001, 13485.

AS9100

Certified to train Fork Lift Drivers, Do “Fit Testing of Respirators” and CPR.

Rapport Leadership International – Leadership Building I and Power Communications.

SKILLS

Audit Ready 24/7 CAPA Investigation & Close out Cost Analysis

Documentation Inventory Control Plant Layout

Process Analysis Process Design Process Documentation

Programs Implemented Requirements Planning Regulatory Management

SOP Writing Standards Development Statics Analysis

Specifications Interpreted Supplier Audits Team Building (Humble, Hungry, Smart)

Programs Proficient: MS – Office – Word, Excel, Project, MRP II, JD Edwards, Batch Master, Unipoint

EXPERIENCE:

Presently Surgical Frontiers, Logan, Utah

and Zigg Design, Nibley, Utah

Quality Manager for 6 Medical Device development companies & acting Vice President of Quality for 1. Responsible for all of the Quality functions – Manage and development of our Quality systems, all internal audits of our Quality systems (SOP’s, Exhibits, Work Instructions, and so forth) and all external audits of our suppliers (level 1 to 4), will host and conduct ISO, FDA and other potential 3rd party audits. We are an ISO 13485 facility that designs and validated designs for the development of new and innovative orthopedic devices – feet, shoulders, ribs, anywhere a bone can be broken we are working on an implant. I also manage the receiving of Prototypes, their inspection to specification/drawings; these could end up in a cadaver or in an actual clinical trial.

4/2015 to 2016 Global Health Industries, Ogden, Utah

Senior Quality Manager & member of The Sr. Management Team, Responsible for all of the Quality functions with our Dietary Supplement company, Quality Control and Quality Assurance, Release for Sale and all Audit function, both Regulatory (FDA, TGA & CA), Third Party (UL, NSF, Halal, Kosher) and all Customer Audits. Administer the Customer Complaints and CAPA program - investigation, documentation and through resolution. Managed a staff of 15 for an excellent quality record with many contract customers throughout the Dietary Supplement Industry. Approved all Certificates of Analysis, Certificates of Manufacturing, Deviation, Change Controls and SOP revisions all of which were developed out of the various ISO standards – ISO2859, ISO9001, and ISO13485. Managed all of this through the use of our QMS system – UniPoint and with the use of Batch Master our MRP system. Managed the HACCP program for each facility. Performed and managed all Validation programs/efforts.

9/2014 to 4/2015 Ardent Mills, Ogden, Utah

Laborites Manager As a consultant I setup all of the methods, for there testing lab AOAC, BAM, and USP for the testing of all incoming wheat and outgoing flour to determine its adherence to the various customer and internal specifications to assure our company that we were using the best raw material available and to sell the best quality product to the many customers throughout our industry. Participated in the HACCP program.

3/2003 to 3/2014 Quikrete Companies, Salt Lake City, Utah

Production Manager Responsible for the entire manufacturing operations: production:- developed schedule & shift coordination for area supervision, material requirements planning/purchasing/Supply Chain Management through the use of JD Edwards – manage area budgets, costs & inventory, quality - auditing & ensure, engineering – process control to ensure the health, safety and environmental compliance of our facility, warehousing – inventory control. Lead the organization in the coordination between production and maintenance. I participated in capital budget and business development planning. We manufacture a verity of cementations products primarily for the construction trade and the large “do it yourself” box stores.

12/2001 to 3/2003 GreenEarth Packaging, Ogden, Utah

Project Mgr/Plant Mgr. (to be) Project Manager - working with a research company that has developed a biodegradable material that we are projected to use to manufacture into single use plates and bowls for such retail customers as Wal-Mart. It is my responsibility to purchase as necessary, design as necessary, review machinery, tooling and process designs as required and to manage the transition of this technology from EarthShell to us and to eventually start up a manufacturing plant in Utah and act as its Plant Manager. Utah plant cancelled.

QE2’S, Quality Environmental Engineering Systems, Layton, Utah

Project Engineer/Manager I formed a consulting group named QE2’S that conducts Project Management projects for companies such as Parvus, GreenEarth Packing/EarthShell, and the US Air Force. Projects range from Dietary Supplement quality, Industrial and Manufacturing systems development, developing and writing of test plans for high tech government contract equipment using AS9100, IOS9001, ISO 2385 and ISO 13485, writing and implementing Safety Programs, conducting training and pre-auditing of facilities that were gearing for US and Foreign regulatory registration, Environmental waste management, both prevention and clean-up, and new plant construction.

7/96 to 12/2001 Cornerstone Nutritional Labs, Farmington, Utah

Quality Assurance Manager As the Quality Assurance Manager my primary responsibility is to ensure the Safe, Pure and Effective manufacturing of Nutritional Supplement products through the use of cGMP’s and APICS certification. Responsible to perform, evaluate, determine cause & corrective action, implement change and follow-up on all internal audits for all company systems and report to executive management the results of all audits. All aspects of the quality assurance programs (i.e. SOP’s, Company, Customer & Process Audits, Supplier Audits, Certifications, Raw Material & Product Specifications, Calibration and Metrology Activity, Capability Studies and Finished Goods Inspections) were all managed by me. Additional responsibilities included the coordination of our MRP2 program/Supply Chain Management to facilitate on time testing of all raw materials, in-process materials, and finished goods to guarantee a safe product, the cause and corrective action for all customer complaints, new product review of all projects including the Labeling for adherence to the DSHEA regulations, the review and approval of a Master Production Records “MPRs” and Supervision of our Quality Assurance team. All company wide training for GMP’s Safety and SOP’s was also my responsibility. In 1996 no SOP manual, Quality Manual or recognized Certifications existed, while today we have certifications in 9 countries (Australia “TGA”, Canada, Germany, England, Japan, Korea, Hong Kong, Taiwan and US) and both an SOP & Quality Manual.

10/91 to 7/96 Levolor Home Fashions, Ogden, Utah

Quality Engineer (12/93 to 7/96) As the corporate Quality Engineer my primary responsibility was to certify suppliers, through the survey, audit and follow-up of all new and existing suppliers with contract management review and modification of all purchasing specifications all with respect to the manufacturing of window coverings. Additional responsibilities included the constant review, and modification of all LHF Quality Procedure manuals, the documentation and testing of all products, manage all aspects of Calibration and Metrology, both in-house and subcontract manufactured, and first article approval of all new and modified tooling for components.

Contract Engineer (10/91 to 12/93) Various projects involving preventative maintenance plans, plant start-up, safety & environmental problem resolution and product standards for production efficiencies and product costing. This contract with LHF was as the team leader on a re-engineering project which included the establishment of a Lean Manufacturing Practices, 5S, KanBan, Kaizens and new incentive based standards through MOST.

10/86 to 10/91 Natter Manufacturing, West Jordan, Utah

Engineering Manager Responsible for the management of 17 full-time employees within the product design, cost estimating, manufacturing engineering, maintenance, tool & die design and fabrication group all with respect to the manufacturing of precision sheet metal components (computer and medical devices). Primary responsibility for capital equipment, tooling specification & acquisition, budget & business plan preparation, plant layout, tool design cost review, customer specification interface and hazardous waste management. (budget 2.5 million). Participated in and assisted in our becoming ISO 9000/9001 Certified, personally implementing many of the ISO Standards and AS9100. Responsible to perform, evaluate, determine cause & corrective action, implement change and follow-up on all external and internal audits for all Manufacturing / Industrial Engineering systems and report to plant management the results of all such audits.

2/82 to 10/86 Acme Electric Corporation, Salt Late City, Utah

Plant Manager (12/83 to 12/86) Reporting to the Vice President & General Manager. Formulated and recommended manufacturing polices and programs which lead the division in maintaining and improving its competitive position and its profitability all with respect to the manufacturing of electronic components for computers and medical devices. Facility grew from $12M to $24 M in revenue, doubling its size with only minor additions in direct labor. Responsibilities centered around the over-all management, direction, and coordination of plant operations through production supervision, scheduling, engineering, maintenance, warehouse and quality control. Reviewed and acted upon audits from our engineering and quality departments to increase both quality and efficiencies, reporting back to corporate management.

Engineering Manager (2/82 to 12/83) Reporting to the Plant Manager, directed the costing function and its interface with design engineering, sales and the customer. Defined all production perimeters, methods, standards, tooling, capital equipment (purchasing & implementation) and plant layout. Responsible to perform, evaluate, determine cause & corrective action, implement change and follow-up on all internal and external audits for all manufacturing/engineering systems and report to plant management and corporate Industrial Engineering the results of all audits.

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