SALLY

Founder / Business Management Consultant

Sally is a graduate of Rutgers University with a degree in Electrical Engineering.  During her career, she has functioned in Electrical Design Engineering, Quality Assurance and Quality Management roles and she now provides training and consulting services in regulatory compliance, certification and registration.  The breadth of her experience includes the major recognized standards: AS9100, ISO 9001, ISO 13485, ISO 14001, ISO 17025, ISO 45001, IATF 16949,  cGMP, and FDA compliance.  She has led companies to QMS, EMS and OHS certification and is a Certified Quality Management System (QMS) Auditor.  Sally'’s regulatory expertise ranges from upper management level program overviews and strategic planning through mid-management level overview and program structure formation to the procedure development and documentation required for implementation. Her experience also covers industries from electronics and electrical systems to medical devices, automotive components and food processing.

WANDA

Business Management Consultant

Wanda is a quality professional with over 20 years of experience in quality assurance, regulatory compliance, and continuous improvement. She has worked in different management roles in quality and operations of pharmaceutical and medical device manufacturing companies. Wanda is an MBA graduate from Devry University and has a bachelor’s degree in Science. During her career, she has implemented and guided certification efforts on ISO 9001, ISO 13485, FDA Quality System Regulation for medical devices, and cGMP’s for pharma businesses. Additionally, she has provided consulting services to other industries and supported efforts to obtain certifications in a variety of standards, including AS9100, ISO 14001, ISO 17025,  and ISO 45001.  She is also a trainer for Metrology concepts, GD&T ASME Y14.5, SPC, and Lean Six Sigma tools and methodology.  Wanda is a Certified Lean Six Sigma Green Belt, an ASQ Certified Quality Engineer, and Judge and trainer for the International Team Excellence Award competition at the ASQ World Conference.

DONNA

Business Management Consultant

In addition to being a college instructor, Donna is a documentation-oriented, degreed scientific/engineering professional from the highly-regulated, high-reliability and disciplined change control environments of the aerospace and defense industries.

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Aerospace and defense work require consistent repeatability and stringent adherence to standards and specifications, not unlike the medical and pharmaceutical industries where compliance with FDA regulations is critical. The majority of Donna’s experience is in engineering technology R&D, quality assurance (IATF 16949, ISO 9001, ISO13485, AS9100, ISO17025 standards), concurrent engineering (DFMA), manufacturing, fabrication, technical writing and documentation.  Donna also served in the military, both as an enlisted petty officer and commissioned line officer (US Coast Guard; US Navy.)  

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Donna has amassed a large arsenal of technical/scientific experience and a wide exposure to multiple industries including defense, aerospace, medical, shipbuilding, aviation, solar energy/photovoltaics, nuclear energy, electronics, semiconductors, photonics/optics, telecommunications, consumer products and proof testing machine technology for the rigging industry.

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Master’s Degree: Interdisciplinary - Rutgers University

Bachelor’s Degree:  Engineering - The College of New Jersey

JOHN

Business Management Consultant

John is a quality and improvement professional with clear track record of success in small and large organizations.   John has significant experience across a wide range of industries including: medical devices, OTC, automotive, machine shop, military, consumer, metals and electronic items.   He is experienced in both batch and discrete processes including machining, converting and packaging.   John is recognized for his strength in continuous improvement, compliance work and team leadership.  

John is an IATF 16949 Team Auditor and an ISO 9001 Lead Auditor for top US Registrars. 

He is also a certified ASQ Biomedical Auditor and a certified Six Sigma Black Belt. 

John’s specialties include:  AS9100, IATF 16949 and Core Tools, ISO 9001, ISO 13485 and cGMP, Lean Manufacturing, Six Sigma, and more. 

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Master’s Degree:  Management - Widener University

Bachelor’s Degree:  Industrial Engineering - Drexel University