Joseph Azary III, president of Azary Technologies, LLC, a medical device consulting firm based out of Shelton, Ct., is assisting Mack Molding’s Northern Operations with quality system development as it relates to ISO 13485 and U.S. FDA requirements. Azary has audited hundreds of companies for compliance with ISO and FDA standards, ranging from small start-ups to Fortune 500 corporations and international conglomerates.
Azary holds a technical undergraduate degree in biological sciences and a graduate degree in business administration (MBA). He has been Regulatory Affairs Certified (RAC) since 1996, and is an ASQ Certified Quality Auditor (CQA), as well as a Certified Lead Assessor for ISO 9001:2000.
With 15 years in various regulatory affairs and quality assurance positions in the healthcare industry, Azary has worked with all types of medical devices, including software based, radiological, cardiovascular, gynecological, neurological, surgical, endoscopic, and orthopedic devices, as well as drug/device combination products, implantables, sterile disposables and capital equipment.
Azary was the former chairman of the American Society for Quality (ASQ), Southern Connecticut section (2002-2004), and is the current co-president of the Regulatory Affairs Professionals Society (RAPS), Southern Connecticut chapter.
Also new to the Quality Department are Fan Cruickshank, quality engineer, and Kathleen Bennett, quality clerk/technician.
Cruickshank joined Mack from Regeneron Pharmaceuticals, Rensselaer, N.Y., where she worked for five years in various cell culture manufacturing and quality positions. As a quality specialist, she was responsible for performing deviation investigations and documentation approvals, as well as conducting GMP and compliance training. Other experience included validation, internal auditing and the development and implementation of a new training program.
Before that, Cruickshank was a research assistant at Montana State University, where she earned a bachelor’s degree in biochemistry. She has also completed leadership coursework through The Coaches Training Institute, San Rafael, Calif., and is certified as a lead auditor for ISO 9001:2000.
Outside of her professional activities, Cruickshank coordinates a sponsorship program for an orphanage in Mexico. Through the team’s efforts, both sponsorships and orphanage capacity have tripled over the last two years.
Kathleen Bennett brings 26 years of medical device manufacturing expertise to Mack, with a concentration in quality assurance. Most recently, she was a quality assurance inspector for Tyco Healthcare, Kendall Sheridan, Argyle, N.Y. Earlier, she worked for 23 years for Mallinckrodt Critical Care, also in Argyle, where she moved through positions of increasing responsibility within the Quality Department.
A graduate of Adirondack Community College, part of the State University of New York (SUNY) system, Bennett holds a degree in Applied Science. She has also completed coursework of the Juran Institute of Quality Improvement & Facilitation, Southbury, Ct., and is a certified ISO 9001:2000 auditor.
Beefing up Mack’s product design and development services are Randy Pell, senior staff engineer, and Craig Pine, program engineer, both at the headquarters plant.
Previously with Mack for eight years, Pell has rejoined the company after a brief stint as engineering manager at Hy-Ten Plastics, Inc., Milford, N.H. He has returned to the Application Development Center, where he will focus primarily on the design and development of medical instruments.
Before Mack, Pell owned and operated Pell Design, a plastic part and mold design company, for 10 years. He holds a degree in mechanical engineering from Broome Community College, Binghamton, N.Y., a part of the State University of New York (SUNY) system.
Craig Pine joins Mack from NSK Steering Systems America, Inc., Bennington, Vt., where he was a project leader responsible for managing cross-functional program launch teams from award of business through production start-up. Earlier, he was a quality assurance engineer for the company. Prior to NSK, Pine was a materials/project engineer for ROCKSHOX, Inc., a San Jose, Calif., mountain bike manufacturer. Before that, he held a variety of engineering positions over the course of nine years with Delphi Engine and Energy Management, General Motors Corp., Rochester, N.Y., where he was also a General Motors Scholar.
Pine holds a bachelor’s degree in materials engineering from Rensselaer Polytechnic Institute, Troy, N.Y., and a master’s in manufacturing management from GMI Engineering & Management Institute, Rochester, N.Y.
Three have joined Mack in the area of program and account management: Vladan Jankovic, Northern Operations; and Garth Walbert and Jim Anderson, both with Mack’s Southern Operations.
Jankovic brings 16 years of engineering experience to Mack, where he now serves as a program manager at the headquarters facility. Most recently, he was project engineer for Cooper Industries Ltd., New York City, where he led cross-functional teams to achieve efficiencies in sheet metal, molding and assembly operations. Earlier experiences included stints at Progressive Moulded Products Ltd., a Tier 1 plastic parts supplier in Toronto, Canada, and G.G.S. Plastic Engineering Inc., a Tier 2 supplier, also in Canada.
A native of Yugoslavia, Jankovic holds a bachelor’s degree in mechanical engineering from the University of Belgrade, and recently completed an MBA in finance/management at Fordham University, New York City.
Garth Walbert has joined Mack’s Southern Operations as account manager, where he will be responsible for maintaining and growing business in the heavy truck market. He brings 20 years of plastics industry expertise to the job, ranging from tooling, production and manufacturing management to sales and account development.
Most recently, Walbert was account/territory manager for Gage Industries, Inc. a large plastics thermoformer headquartered in Lake Oswego, Ore. During his 14-year tenure there, he broadened his expertise by working in several departments, from manufacturing to sales. Before that, he was an account manager for six years for TriQuest Precision Plastics, Vancouver, Wash.
Walbert holds a bachelor’s degree in business administration from Oregon State University, and lives in Portland.
Jim Anderson, new account manager at the Inman, S.C., plant, brings to his position 17 years of engineering and supply management experience with Volvo Trucks North America, the Southern Operations’ largest customer. With extensive background in the Class 8 truck market and its related engineering challenges, he has assumed primary account responsibility for Volvo Trucks, Mack Trucks, Findlay Industries and other Volvo/Mack Tier 2 suppliers. For the past eight years, Anderson was Volvo’s senior corporate buyer for interior trim and injection molding. Earlier, he was a senior manufacturing engineer/project manager for exterior plastic body panels.
A graduate of North Carolina A&T State University, Greensboro, N.C., Anderson holds a bachelor’s degree in mechanical engineering. He is a member of the Society of Plastics Engineers, the Society of Automotive Engineers, and the Institute for Supply Management. He has acquired a Purchasing Manager Certification with the Institute for Supply Management.