Consultants

Find someone to help you plot your course

Consultants

NOTE: This listing does not signify endorsement by ASQ, this information is provided to you as a courtesy.

Company	Services
Q&C Systems Services, Inc. Bob Wittendorf, President 484-478-2470 rwwitten@verizon.net	Providing consulting for FDA quality systems regulation, established and improved. FDA compliance for medical devices and pharmaceuticals.
Ray Lotfi Consulting 610-308- 8495 raylotfi@gmail.com raylotfi@comcast.net	Validation specialist for medical devices, product and process improvement, cost cutting, and global outsourcing.
Gold Star Water Consultants, Inc. Mikel E. Goldblatt President and Principal Consultant 215-498-5188 info@goldstarh2o.com http://www.goldstarh2o.com/	Water and wastewater systems problem-solving, training, and site-specific practical improvements.
X-Stream LEAN, LLC Alex Malek 484-941-3877 info@xstreamlean.com http://www.xstreamlean.com	Worldwide consulting to companies requiring Lean Six Sigma, executive coaching and mentoring, organizational development and Supply Chain Management
The Brookfield Group, LLC David J. Yamarick, President 484-319-8167 thebrookfieldgroup@comcast.net	Specializing in the “how to” of ISO. Our focus is to increase your capability providing services to free up your company to spend its efforts on core business processes. Add value to your QMS and EMS. Outsource Services for ISO Management Systems
John J. Salera and Associates 215-968-0310	Preparation of quality system manuals and procedures to comply with ISO9000, QS9000 and Department of Defense requirements. Design of SPC systems, including SPC management plans. Assistance in configuration management programs, failure analysis, etc.
Keystone Regulatory Services, LLC William G. McLain 717-656-9656 bill.mclain@keystoneregulatory.com www.keystoneregulatory.com	Full-service regulatory affairs and quality management system consulting for the medical device industry. Quality system (21 CFR 820; ISO 13485:2003) and risk management (ISO 14971:2000) system analysis, auditing, implementation and training, pre-market regulatory strategy and support, agency dispute resolution plus many others.
Master Quality Consulting Michael J. McMaster, ASQ CQA, CQE, CQMgr 609-304-6314 masterquality@comcast.net	Providing the pharmaceutical, biotechnology and medical device industries proven auditing, cGMP training, quality system and regulatory compliance consulting services.
Nash Associates Robert J. Nash, Ph.D. 610-363-6147 drrjnash@comcast.net	Providing consulting with ISO 9000, FDA cGMP, FMEA, SPC, design of experiments, applied statistics and statistical reports, survey construction and analysis, sustainable excellence. More than 100 corporate clients since 1986.
Optima Performance, Inc. Arthur W. Crowley John V. Lawson 610-212-2336 artcrowley1879@gmail.com	Management Services, business performance assessment, planning, and implementing, QM System methods and processes to assure optimized performance. Business process mapping and real time measures for monitoring and improvement. Prepare clients for ISO 9000 registration and provide associated tools and software. A certified Plexus training company.
Quality Systems Tom Davis 610-828-1650	Provides proven customized TQM consulting and training services, including compliance with ISO and QS standards. With management participation, facilitators and teams are trained to continually lower costs and increase productivity.
Xybion Corporation 215-638-9700 sales@xybion.com www.xybion.com	Provides enterprise-wide compliance solutions to regulated industries in the pharmaceutical, medical device, diagnostic and biotechnology sectors. Delivers a comprehensive suite of validation, technology, regulatory and business solutions.
Storti Quality Consulting, Inc. Ralph J. Storti ANSI-RAB Accredited Internal and Lead Auditor 215-657-08377 stortiqci@verizon.net	Provides quality program development, audit and consulting services to utility, construction, manufacturing and industrial companies. Twenty years of quality Assurance and quality control experience. Providing training, perform surveys/assessments of existing programs and processes. Conduct audits and write policies and procedures.
Total Quality Management Joseph Siegel 610-664-8816 eljo@snip.net	Helping clients comply with ISO9000, using Six Sigma tools to create an environment stressing reduction of variability of key manufacturing elements through FMECA, Pareto analysis, quality function deployment, sampling plans, control charting, and designed experiments. Provide SPC training of these concepts.
Validation Associates, Inc. Nancy Tucker 215-354-1720 nancy.tucker@validassoc.com www.validassoc.com	Providing the pharmaceutical, biotechnology, and medical device industries with computer system validation project consulting and training services.