Manufacturing Director/Manager, Quality Director/Manager

A. JOHN MOSTOUFI Email: e2xfq8@r.postjobfree.com

*** **** **. ▪ Sussex, NJ 07461 H: 973-***-****

QUALITY/MANUFACTURING/ENGINEERING LEADER

Planning and Organizational Leadership // Validation // Medical Device Manufacturing // cGMP // SOP //

Pharmaceutical // ERP/MRP // Operations Optimization // Lean Manufacturing // CAPA // Six Sigma // ISO 9000 // Engineering, MBA.

Design and execution of Operation systems to meet business, financial, regulatory and customer demands. Change agent and leader for an organization’s journey toward Lean Enterprise Transformation. Experienced in Pharmaceutical and Medical Device Manufacturing environments that meet FDA’s requirement. Demonstrated track record of strong, effective leadership for profitability, production, supplier management, quality, and safety. customer service and productivity improvement.

CAREER ACCOMPLISHMENTS

INTELLPRO SYSTEMS, Sparta, New Jersey - Operations / Quality Director 2002 – Present

Manufacturing and Quality systems-Consulting Company

Industries Served: Medical Device Manufacturing, Pharmaceutical, and some Tissue- based allograft.

• Design, train, and implement manufacturing and quality assurance systems ( Including regulatory Industries).

• Planning and developing organizational focus to increase customer satisfaction. Utilizing Lean manufacturing, Six Sigma, and other continuous improvement tools.

• Constant monitoring for improvements: Constant watch for possible removal of additional non-value activities.

Responsible for the overall management of the following functions: , Quality and Regulatory Affairs, Manufacturing / Quality Engineering, and customer interactions.

With the help of the management team , responsible for the design, training, and implementation of a Manufacturing and Quality system that met FDA’s QSR and ISO 13485 regulations . These programs include complete Medical Device Manufacturing Process Management and Document Management to meet Pharmaceutical and Medical Device Manufacturing for FDA requirements. The accomplishment have provided a substantial growth in sales in the health care industry for the clients. In one case the growth in sales has resulted so far 27% increase in the operating profits.

In addition to the above-mentioned program, other accomplishments within the Quality system include the establishment of a validation program for Injection Molding processes for a medical Device, a CAPA program that has proven to be very effective in elimination of 26% of customer complaints within the first year.

Reduction of internal and external rejects by more than 18% through use of continuous improvement tools such as six sigma, Lean manufacturing concepts, and etc.

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ATP/HBC. Division of Applied Tech Products (ATP), Sparta, New Jersey 1999 – 2002

Applied Tech products A $260 million group of companies with holdings in the Health & Beauty Care Division, medical device, engineering plastics, and automotive products industries. The ATP Health & Beauty Care Group manufactures custom designed closures, dispensers and packaging for high-end health and beauty aid companies and for the OTC pharmaceutical industry. Operations are in Sparta, NJ, Stratford, CT and Bay shore, NY.

Director of Quality Assurance/Operations:

• Responsible for total quality and processing management, production staff, and quality operations at several Injection Molding manufacturing facilities in addition to directing Divisional performance in terms of individual Plants.

• Managed six direct reports as well as customer interaction.

• Managed multi-plant facilities, responsible for the implementation of ISO compliant Quality Management Systems.

• Responsible for the Implementation of CAPA programs.

• Registered manufacturing operations with the appropriate FDA agencies.

• Gained approval and supplied components to pharmaceutical companies.

• Implemented various Lean Manufacturing, MRP, and Total Quality initiatives at several facilities that met FDA and cGMP regulations and requirements and resulted in:

 Increased average operator productivity from 65% to 86%, a 32% improvement. Using Lean tools like process mapping and value analysis, etc.

 Improved process capability (Cpk > 1.3) and implementation of ISO 9000 quality system. Using 6-sigma, validation and other continuous improvement tools.

 Reduced internal rejects 50% and cost of quality by 25%.

 Achieved 45% improvement in customer satisfaction.

• Reduced number of accident reports 60% by collaborating with OSHA to implement safety program.

POLY – SEAL CORPORATION, Baltimore, Maryland 1990 – 1999

A $60 million Injection Molding Manufacturer of closures since 1934, offering the most diverse closure product line in the world. Custom designed packaging for pharmaceutical and cosmetic industries. Three manufacturing facilities.

Director of Quality Assurance/Operations:

• Developed and implemented quality management system, SPC training & implementation programs, and Cost of Quality program at all facilities, which met FDA and cGMP requirements.

• Served as key member for ERP system implementation and Team Leader for establishing and achieving ISO 9000 certification, increasing customer satisfaction with product quality and delivery.

• Developed and implemented new quality management systems to meet FDA and cGMP requirement, Including 10000 clean room classification for injection molding and assembly.

• SPC training & implementation programs, for multiple facilities.

• Established continuous improvement through D.O.E. and other statistical means of process capability studies (Six Sigma) capable of producing finished products that met the strictest requirements; resulting in 50% reduction in the number of customer complaints within one year.

• Reduced internal rejects by 57% within first year of the implementation. Increasing customer satisfaction with product quality, delivery, and service.

• Establishing process qualification and validation programs that met minimum Cpk of > 1.33.

• Established and implemented Cost of Quality program at all facilities.

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WHEATON INJECTION MOLDING COMPANY, Millville, New Jersey 1988 – 1989

A $22 million Manufacturer of pharmaceutical and cosmetic caps and auto steering gears.

Plant Manager

• Oversaw 5 direct reports and all manufacturing and support functions for a facility with 40 injection molding presses, including production, quality, customer interaction, inventory management, and scheduling.

• Improved productivity 20%, Labor Variance 64%, and on-time shipping from 84% to 95% by establishing and implementing mold / press maintenance programs, modifying quality procedures, and creating management reports that monitored critical operating metrics.

• Reduced Work in Process inventory (WIP) by 80% and total inventory by 30%.

• Improved value added per employee by 29% and increased sales 33% per employee.

• Increased machine utilization above 95%, improved Year 1 profit by 15%, and developed Financial, Operational & Quality Systems as a result of continuous improvement.

OWENS – ILLINOIS CORPORATION, New Jersey / North Carolina / Ohio 1978 – 1988

One of the world's largest and most diversified manufacturers of glass and plastics packaging products. With $3+ billion global operations.

Quality Assurance Manager (1985 – 1988), Hamlet, North Carolina / Buena, New Jersey – Injection Molding Facilities.

• Managed five direct reports and all quality functions in Hamlet from 1985 – 1987 and at the Buena Plant from 1987 – 1988, with injection molding, injection blow molding, assembly, and silk screening operations.

• Trained Quality inspectors on SPC and GMP and established other related training programs; implemented Juran’s Total Quality training program.

• Reduced quality complaints by 30% while business volume increased by more than 40%.

Quality Assurance Supervisor , Hamlet, North Carolina – Injection & Compression molding

• Planned and supervised the day-to-day activities of 21 inspectors, chief inspectors, and lab technicians and implemented procedures for the Hamlet plastics processing and assembly facility.

Additional Experience at Owens-Illinois included Process Engineer, Production Planning & Inventory Analyst , and Industrial Engineer.

EDUCATION

UNIVERSITY OF TOLEDO, Toledo, Ohio

Master of Business Administration, Operations Analysis Specialization

Bachelor of Science in Industrial and Mechanical Engineering

PROFESSIONAL AFFILIATIONS

American Society for Quality

Society of Manufacturing Engineers

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