Arrow International, Inc. Names Kenneth E. Imler Senior Vice President Of Regulatory Affairs And Quality Assurance

November 2, 2005 |

3 min read

READING, Pa., Nov. 2 /PRNewswire-FirstCall/ -- Arrow International today announced that it has named Kenneth E. Imler to the newly-created position of Senior Vice President of Regulatory Affairs and Quality Assurance. Mr. Imler will manage and oversee the Company’s Regulatory Affairs and Quality Assurance systems, programs and personnel. He will serve on Arrow’s Management Executive Committee.

Mr. Imler has been the lead consultant from Quintiles Consulting, a provider of global consulting services to the medical device, pharmaceutical and biologics industry, working on-site at Arrow for the past nine months. He will be the Company’s main point of contact with the United States Food and Drug Administration (FDA), helping to ensure that Arrow continues to meet, and in many respects even exceeds, FDA and international regulatory requirements in its products, manufacturing processes, procedures, and systems. He also will guide Arrow in its efforts to implement rigorous compliance procedures designed to achieve the highest practical levels of quality assurance as part of its Project Operational Excellence and attain Six Sigma quality over the longer term.

Carl G. Anderson Jr., Arrow’s Chairman and CEO, said, “Since Ken Imler has been working with Arrow, he is familiar with our Company and our people and the objectives of our Project Operational Excellence program. We are pleased that he now is joining us full time. His leadership skills, extensive regulatory and compliance experience, and knowledge of quality assurance will be valuable as we continue our efforts to develop and implement best practices and outstanding business systems company-wide. Our goal is to enable Arrow to achieve operational process excellence in the key areas of product quality, safety, customer service and cost. We have a strong management team in place and a workforce committed to making that happen.”

Mr. Imler, 56, most recently served as a Principal Consultant for Quintiles Consulting, a leading quality systems and regulatory consulting firm since April 1999. From March 1997 to April 1999, he was President and Principal of KEI consulting, a private quality assurance and regulatory affairs consulting company. He served as Director of Quality Assurance and Regulatory Affairs for Medtronic Blood Management, a developer and manufacturer of hemostasis and thrombosis in-vitro diagnostics and auto transfusion systems from 1995 to 1997. From 1993 to 1995, Mr. Imler was Director of Quality Assurance and Regulatory Affairs for COBE Renal Care, a developer and manufacturer of renal dialysis equipment and disposables. From 1986 to 1993, he served as Director of Quality Assurance and Regulatory Affairs for Medtronic Heart Valve Division, a developer and manufacturer of biologic heart valves and associated cardiac surgery devices. Prior to 1986, Mr. Imler held management positions in Quality Assurance and Regulatory Affairs for SmithKline/Beckman Instruments, a developer and manufacturer of clinical laboratory equipment and in-vitro diagnostics, and Behring Diagnostics, a developer and manufacturer of in-vitro diagnostics.

Mr. Imler holds a Bachelor of Science degree from the University of California, Riverside, CA and an MBA from National University in San Diego. He is an ISO Certified Lead Auditor and holds a Black Belt in Six Sigma. Mr. Imler is the author of the book “Get it Right; A Guide to Strategic Quality Systems.”