Enhancing internal expertise as producing members of your team

QSN consultants are highly skilled, specialty-knowledge resources that are hand-selected for their versatile backgrounds, business acumen and interpersonal skills. Through their knowledge of quality, engineering, science, and business process, they have the comprehensive skill-sets to be producing members of the team. They enhance internal expertise by using best-in-class tools to get the job done, and they transfer knowledge and skill-set to your internal team members along the way.

Brette Travaglio

President and Principal Consultant

Seasoned engineering professional with extensive experience in healthcare and medical device/pharmaceutical manufacturing, with key roles in regulatory affairs, quality engineering, regulatory compliance, quality assurance, process validation, and quality control. Read more »

Laurie Auerbach

Consultant

Results-driven professional with solid technical and compliance knowledge, skilled in quality systems implementations, design controls, DHF preparation, compliance and supplier audits, software validation, document and change control, regulatory affairs, and project management. Read more »

Jitendra J. Balar

Consultant

Professional with years of experience, skilled in analytical chemistry, quality control, quality assurance, quality systems, and regulatory affairs. Highly credentialed and experienced in medical device, drug, and fine chemicals manufacturing industries. Read more »

Alex T. Bourdon

Consultant

Highly accomplished medical device executive who combines manufacturing expertise with solid quality and compliance experience to develop and implement systems and culture that enhance cross-functional collaboration. Read more »

Jaclyn Budreckis

Consultant

Talented, innovative, and energetic professional with solid quality engineering and process improvement expertise. Highly credentialed with years of experience working with leading, global medical device and biotechnology manufacturers. Read more »

Erik Christie

Consultant

Pharmaceutical Professional with over 20 years of solid technical and compliance knowledge working in top global pharmaceutical and biologics manufacturing companies. Read more »

Wei Cai

Consultant

Professional engineering executive with solid technical and compliance knowledge. Highly credentialed with years of experience working with global medical device manufacturers. Read more »

Joseph C. Crea

Consultant

Professional with pre-clinical/concept through product launch experience in quality systems, quality management, quality assurance, contract manufacturing, and operations. Over 30 years working with drug, medical device, combination, and consumer products manufacturers. Read more »

Carolyn de Jonge

Consultant

Professional with compliance and quality management systems knowledge. Years of experience with medical device and drug manufacturers. Background concentrated in in-vitro diagnostics and sterile/reusable surgical medical device products. Read more »

Monica Ferrante

Consultant

Professional medical device consultant with solid technical and compliance knowledge, skilled in quality systems, process validation, product development and improvement, and regulatory approvals and submissions. Read more »

David V. Gorky

Consultant

Professional with solid technical background, skilled in product development, program development, project management, and manufacturing engineering. Highly credentialed engineer with years of experience with top global medical device and drug manufacturers. Read more »

Paul V. Gorky

Consultant

Experienced professional with comprehensive packaging development/project engineering background with pharmaceutical companies, world’s leading direct seller of beauty products, and preeminent consumer foods. Read more »

Daniel Haders

Consultant

Highly credentialed biotechnology professional with operations and project management experience supporting many biomaterials engineering projects and applications. Read more »

Philippe R. Hebert

Consultant

Multilingual professional project manager with over 35 years of consulting experience focused on supply chain issues with expertise in materials, manufacturing, purchasing, operations, logistics, warehousing, distribution, and regulatory compliance. Read more »

Lizauri Hernandez

Consultant

Professional, bilingual consultant with sixteen years of experience in quality compliance, validation and infrastructure systems (Biotechnology, Vaccines and Pharmaceuticals). Broad experiences gained working for pharmaceutical, device and biologics manufacturers. Read more »

Keith Holland

Consultant

Accomplished professional skilled in operations, distribution, supply chain, logistics, production, warehousing, and packaging. Proven record as demonstrated working with global drug manufacturers in the pharmaceutical industry. Read more »

James E. (Jim) Ingram, CPP

Consultant

Consultant with over 30 years of management experience in packaging, labeling, change control, production engineering, purchasing, and operations. Technical and project management knowledge in drug, cosmetic, medical device, and food manufacturing. Read more »

Bikram Kamboj, RABQSA

Consultant

Professional consultant having executive experience, with expertise as lead or principle certified auditor responsible for audit planning, scheduling, conducting, and reporting for numerous ISO 9001, ISO 14001, ISO 13485, and OHSAS 18001 management systems. Read more »

Elaine Kindell

Consultant

Effective leader with successful reputation for heading Quality System, Compliance, R&D, and Quality Operations organizations in global medical device businesses. Proven ability to develop, maintain and improve quality systems and processes, data governance, team building, collaboration and change management. Read more »

John T. LoPiccolo

Consultant

Professional with years of Project Management, Operations, Compliance, and Validation experience within major Pharmaceutical, Consumer Products and Biologics Manufacturers with demonstrated year-over-year improvements in quality, cost and delivery functions. Read more »

Arthur Madenjian

Consultant

Professional with solid technical and compliance knowledge, skilled in product development, plastics and mechanical engineering, R&D, and program management. Highly credentialed with years of experience in top global medical device manufacturers. Read more »

James Madenjian

Consultant

Professional with over 20 years of experience in design engineering, project management, tooling engineering, plastics and polymer engineering, and manufacturing engineering. Read more »

Mark Magnuson

Consultant

Professional with solid technical and compliance knowledge, skilled in product development of Class I, II, and III medical devices. Extensive experience in global medical device and combination product manufacturing. Read more »

Ron Makar

Consultant

Dedicated, well-organized, professional with vast experience in medical device product development, quality management, quality assurance, and quality engineering, regulatory compliance, process and system engineering, manufacturing and supplier qualification. Read more »

Jonathan Malave

Consultant

Results-oriented, high-energy, hands-on professional, whose major strengths include effective leadership, adaptive skill sets, efficient communication, attention to detail, and dutiful respect for compliance within the pharmaceutical and medical device industries. Read more »

Jose Ignacio Mora

Consultant

Professional consultant with solid technical and compliance knowledge with over thirty (30) years of hands-on expertise in the life sciences industry, specifically in medical device and pharmaceutical manufacturing. Read more »

Paul J. Moran

Consultant

Management and technical professional with solid quality assurance, technical service, and compliance knowledge. Extensive experience in medical device, drug, combination, and consumer product manufacturing. Read more »

Linda Morgan

Consultant

Professional with technical and compliance knowledge, skilled in regulatory affairs, quality assurance, operations, and engineering. Highly credentialed with over thirty years of experience working for top global medical device manufacturers. Read more »

Robin Norris

Consultant

Quality Management professional with extensive leadership experience in top global medical diagnostic manufacturers. Strong background in clinical diagnostic systems and services. Read more »

Dario Olivera

Consultant

Professional with over 30 years of solid technical and compliance knowledge in manufacturing, operations, and technical management. Experience working in top global medical device, drug, biologics, and combination product manufacturing companies. Read more »

Scott C. Otto

Consultant

Consulting professional with over 33 years of extensive experience in package engineering. Experience working with high profile pharmaceutical and medical device manufacturers. Read more »

Robert J. Serra

Consultant

Professional with strong scientific and technical expertise in chemistry, product development, quality assurance, and manufacturing. Experience working in major drug, biologics, and medical device corporations. Read more »

Anthony “Tony” Simiele

Consultant

Experienced medical device professional with an accomplished 25+ year career of designing, launching, producing and supporting medical devices globally. Have taken several Class II systems from concept through market end of life for Fortune 500 medical device companies. Read more »

Jeffrey M. Singer, Ph.D.

Consultant

Senior professional with technical, managerial, business process, and scientific knowledge, skilled in regulatory compliance, analytical development, product development, and quality control. Read more »

Mike Spears

Consultant

Professional with solid technical and compliance knowledge, skilled in research and development, manufacturing, operations, validation, and quality engineering. Broad experience with pharmaceutical, device and biologics manufacturers. Read more »

Traci Van Arsdale

Consultant

Professional with strong experience in quality assurance, regulatory affairs, program management, and laboratory management. Highly credentialed with years of experience in top drug, biologics, and medical device manufacturing industries. Read more »

Eliot Zaiken, CQE, CQA

Consultant

Results-driven medical device professional with extensive background and experience in project/program management, product design and development, design controls, and DHF remediation for global medical device companies. Read more »

Steven Zilli, Ph.D.

Consultant

Senior Pharmaceutical Professional with over 35 years of diverse and progressive technical and compliance knowledge in R&D quality assurance, regulatory compliance, manufacturing, quality control, and packaging. Read more »