James McGhan

Cover Letter

Please accept the attached resume for your open position. I have a vast amount of knowledge and direct experience in the highlighted requirements for this position. I am looking for a position in which I can prove myself and grow with the company as the company needs me. I want to develop a long-lasting career with your company. Here are some highlights from my career that would contribute to your open position:

I have direct experience with injection molding, compression molding, vacuum molding, CNC machining of plastics, elastomeric compounding and processes (milling, blending, and molding)

I have managed machinists, Engineers, material handlers, quality specialists, and PhD scientists into cohesive, functional teams.

I have been responsible for the budgets and P&L of operations with revenues of $85M…

I have extensive experience of budget development, presentation, and implementation at the company and departmental level.

I have been formally trained at the Lean Bronze Level and the API-Q1 level.

I have managed the development, regulatory approval process, production ramp-up, and global market introduction of a number of medical devices, laser-based sensing systems, and highly-regulated technology-based systems.

I have managed the electronic and optical assembly of laser-based (DTS, DAS, and PGI) systems. The manufacturing was ISO Certified, ATEX certified, and audited annually by a number of third party inspector for global customers.

I am a business consultant, live in the Houston area and can begin work for you almost immediately.

I have successfully managed operations throughout my career that required strict safety programs, without incident.

I have direct knowledge and experience managing ISO audited and certified manufacturing facilities, USFDA regulated facilities, and internationally-regulated facilities.

I have extensive consulting background presenting before groups…budgets, goals, and objectives…but now I am looking to be able to stay with a company longer than just a contract and build a career with them as the company grows…I am very loyal and stay with a company once hired.

I have managed Teams of people throughout my career from small 5-10 Lean Kaizen Teams to entire companies of over 100 people!

Thank you for the consideration….

James McGhan

Please Consider the Following,

I have spent my career as the driver for meeting goals and directing companies and projects through to on-time commitments. I have been the person responsible for taking the product idea through refinement, structure, and implementation. I have been the person that would carry forward product ideas, change the direction of the operation on a dime, and handle all of the organizational aspects of the business. I know how to form solid Teams of cross-functional members, set objectives, motivate to goals, and meet deadlines.

Throughout my business career, I have been responsible for the management of manufacturing facilities as diverse as machine shops to Class 1000 clean rooms. I am very comfortable in a manufacturing environment that includes a machine floor, as well as, production that requires a high level of operator assembly in a clean room environment. I have direct experience with injection molding and extrusion operations, electronics assembly, and medical device production. I have been the lead company representative for regulatory inspections (USFDA and ISO Notified Bodies). I have developed, implemented and managed compliance programs, as well as, changed company cultures to reflect required FDA. OSHA, and ISO compliance guidelines.

I have been directly responsible for developing, negotiating, and implementing departmental budgets and have been directly responsible for production planning. I have been directly responsible for developing manufacturing operations, and managing the daily activities of the business units developed around the new products. I have implemented 5S programs, Lean Manufacturing, regulatory compliance programs, employee appreciation programs, OSHA programs, and vendor audit programs. Each position that I have held has required my constant coordination between manufacturing operations, sales and marketing units, technical support staffs, and corporate management. I am very accustomed to working in highly complex, cross-departmental, matrix companies.

I look forward to discussing my work experiences in more detail and exploring the possibilities of becoming a member of your Team.

Sincerely,

James McGhan

805-***-****

acwxbi@r.postjobfree.com

Houston, TX 77066

James McGhan

Cell: 805-***-****

acwxbi@r.postjobfree.com

MANAGEMENT PROFILE

Manufacturing/Operations Professional

Matrix Management /Regulatory Compliance

Business Restructuring/Lean Manufacturing

Global Corporate Strategy Development and Implementation

During my business career, I have been responsible for operations ranging from injection molding and machine shops to Class 1000 facilities and Class 100 medical device manufacturing. I believe in the power of communication from the employees to all levels of the organization, from each department to every other department, and from facility to facility. Consistent communication of the company vision, translated into individual goals, and achievement recognition are keys to my management philosophies.

Throughout my career, I have been responsible for regulatory compliance and have implemented company-wide compliance programs that have changed the company culture. I have implemented Lean Thinking practices to drive production efficiencies, operator enthusiasm, and company pride. I have always united the employees into a Team with definable goals, team development, and individual recognition.

I have managed the development programs, clinical programs, and subsequent business units for Class I, Class II, and Class III medical devices through the FDA, EU, TGA, and COFEPRIS, such as the first intraocular lenses for cataract surgery, the first lap-band for obesity surgery, the first Intragastric balloon for obesity, and implantable devices for plastic surgery. I am a capable manager of diverse employee populations, skilled in communications, driving goal achievements and motivating all employees, across cultural barriers, for a global corporate harmonization.

EXPERIENCE

9YEARS – Present

Owner of Global Management Consulting, (GMC), Houston, TX. -a business solutions consulting firm specializing in the custom formulation of business strategies in high tech manufacturing. GMC develops specific programs for companies ranging from start-up businesses to well-established corporations with services ranging from the production of professional business plans and models, the establishment of worldwide operations from site location through to production management, project and personnel management, and restructuring underperforming business units. Through the GMC expertise and management in the areas of ISO certification, companies have been able to develop a Quality Management System (QMS), successfully pass a certifying audit, and are able to move forward with their products carrying the CE Mark. GMC has developed and implemented Lean Thinking throughout organizations through Kaizen, Kata, and other team-building programs. Throughout the years, GMC has gained recognition for…

Developing high tech and medical device products from conception to market.

Managing the implementation of ISO and Lean manufacturing processes, procedures, and operator training through company-wide cultural participation.

Designing product branding, packaging, and marketing materials.

Managing the design, validation, and launch of websites.

Supervising production efficiency programs through company-wide initiatives that have resulted in lowering the cost of goods.

Conducting regulatory compliance audits, designing corrective action plans, and implementing company-wide changes.

8 YEARS

Operations Manager of MediCor Ltd., a global health care company incorporated in 1999 to acquire, develop, manufacture and market products primarily for the medical device markets. Responsible for the facility compliance to Good Manufacturing Practices (cGMP), Quality System Regulations, CE Mark registrations, and ISO certifications producing specific product and brand name lines. Products were sold in over 25 countries around the world. The Company sold products to hospitals, surgical centers and physicians primarily through distributors, as well as through direct sales personnel. The product line focus was on technologies and products for reconstructive surgery and dermatology.

Responsible for consistent quarter over comparable quarter sales increases of 12-15%

Developed and implemented programs for manufacturing efficiencies that resulted in gross profit increases of 2-5%

Successfully directed corporate continuity programs across cultural and nationality diversities

Developed and implemented programs for company pride and employee recognition

Developed and implemented global sales and marketing programs that drove sales through direct sales and distributor sales

Developed and implemented regulatory strategies that successfully passed inspections by European Notified Bodies

Developed and implemented FDA regulatory strategies for 510k, PMA, and IDE submissions

Successfully recruited industry leading professionals into executive roles

8 YEARS

General Manager of Bioenterics, which developed, manufactured, marketed, and distributed implantable devices for the obesity and general surgery markets. Products developed were the BioEnterics Lap-Band System and the BioEnterics Intragastric Balloon System, which are now owned and sold by Allergan, Inc..

Responsible for the development of all aspects of the business including organizational structure, quality systems, facilities, clinical programs, regulatory strategies, and fiscal authority.

Responsible for the direction of the technical staff from the initial design phase through to commercialization

Responsible for developing and implementing animal clinical trials and then human clinical trials

Responsible for the direction of global sales and marketing programs

Responsible for recruiting and staffing to full production of 75 employees

The current Lap-Band is the same design as developed at BioEnterics and has now been successfully implanted in over 1,000,000 people

4 YEARS

General Manager of Inamed Development Company (IDC), Carpinteria, CA., which developed implantable devices for the obesity and general surgery markets. IDC was responsible for the R&D for Inamed Corporation, transferring the product or process into existing subsidiaries or developing a new standalone subsidiary as was the case for the BioEnterics Lap-Band System.

Successfully managed all aspects of a start-up research and development business, including the development and implementation of product lifecycles, organizational structures, quality systems, regulatory strategies, facilities planning, and business activities.

Successfully managed development teams to advance prototype ideas into manufacturing facilities

Successfully recruited Engineers, technicians, and assembly operators to 25 employees

3 YEARS

Quality Assurance Manager of Westec Plastics, a full service OEM injection molding company. Westec had in-house mold designers, a full service machine shop, and 13 injection molding machines. The Company was centered in the heart of Silicon Valley and had customers such as IBM and Memorex with specifications holding to tight tolerances measured at a number of locations on the parts.

Successfully established, implemented, and monitored quality control criteria per product, interfacing with customers, and supervising three shifts of inspectors (total of 10 inspectors).

Routinely supervised material review board and change control meetings of department heads

Learned the dynamics of a machine floor which included 13 injection molding machines ranging from 1 ton to 100 ton

Learned to manage 3 shifts of personnel

EDUCATION

Santa Barbara City College -Business Administration

University of Phoenix -Business Administration

CERTIFICATIONS

SME Lean Bronze Training Certification

Halliburton Financial Leadership -Mays Business School Texas A&M

Halliburton Business Development Leadership (BLD1)

American Petroleum Institute (API) API Spec Q1 Certification

Bureau Veritas ISO 9001 Internal Auditor Certification

PATENTS

US Patent Number 6,913,626 Medical implant having a bioabsorbable textured surface

US Patent Number 6,733,512 Self-deflating intragastric balloon

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