Edwin Bills, ASQ Fellow, RAC
Advisory Board Member at Prodct- Claim this Profile
Click to upgrade to our gold package
for the full feature experience.
Topline Score
Bio
Dennis Detmer
Ed is a detail oriented employee. I worked with Ed on many projects. Ed was knowledgeable and offered his expertise to the teams. Ed was extremely knowledgeable in his area of expertise, and his participation ensured that the projects and teams finished on time or ahead of schedule. Ed was always available to give advice in regards to Quality and Regulatory issues when needed. Ed provided facts and would provide an opinion when requested. I found Ed to be a highly motivated, and knowledgeable in his field of expertise. If I had the opportunity I would enjoy working with Ed again in a professional capacity. Dennis M. Detmer Technical Product Manager Hill-Rom Co.
Jim Turner
Ed was established as the Supplier Quality Manager at Hill-Rom when I first hired in. I had worked as an Industrial Engineering and Quality Circles Facilitator at another manufacturer, but was cutting my teeth in medical device manufacturing and QA Engineering at Hill-Rom. The system that Ed developed for supplier certification was ahead of its time. It took into account many different facets of the supply chain, ensuring that Hill-Rom's interests were protected by ensuring the suppliers could deliver product, even in the face of challenges. The challenges anticipated ranged from natural disaster to labor disputes. In one case, a supplier experienced a fire at its plant, but was able to begin production in less than a week at a similar plant because it had developed contingency plans required by Ed's certification process. I thank Ed for teaching me the importance of planning ahead and anticipating events in ensuring the continuity of the supply chain.
Dennis Detmer
Ed is a detail oriented employee. I worked with Ed on many projects. Ed was knowledgeable and offered his expertise to the teams. Ed was extremely knowledgeable in his area of expertise, and his participation ensured that the projects and teams finished on time or ahead of schedule. Ed was always available to give advice in regards to Quality and Regulatory issues when needed. Ed provided facts and would provide an opinion when requested. I found Ed to be a highly motivated, and knowledgeable in his field of expertise. If I had the opportunity I would enjoy working with Ed again in a professional capacity. Dennis M. Detmer Technical Product Manager Hill-Rom Co.
Jim Turner
Ed was established as the Supplier Quality Manager at Hill-Rom when I first hired in. I had worked as an Industrial Engineering and Quality Circles Facilitator at another manufacturer, but was cutting my teeth in medical device manufacturing and QA Engineering at Hill-Rom. The system that Ed developed for supplier certification was ahead of its time. It took into account many different facets of the supply chain, ensuring that Hill-Rom's interests were protected by ensuring the suppliers could deliver product, even in the face of challenges. The challenges anticipated ranged from natural disaster to labor disputes. In one case, a supplier experienced a fire at its plant, but was able to begin production in less than a week at a similar plant because it had developed contingency plans required by Ed's certification process. I thank Ed for teaching me the importance of planning ahead and anticipating events in ensuring the continuity of the supply chain.
Dennis Detmer
Ed is a detail oriented employee. I worked with Ed on many projects. Ed was knowledgeable and offered his expertise to the teams. Ed was extremely knowledgeable in his area of expertise, and his participation ensured that the projects and teams finished on time or ahead of schedule. Ed was always available to give advice in regards to Quality and Regulatory issues when needed. Ed provided facts and would provide an opinion when requested. I found Ed to be a highly motivated, and knowledgeable in his field of expertise. If I had the opportunity I would enjoy working with Ed again in a professional capacity. Dennis M. Detmer Technical Product Manager Hill-Rom Co.
Jim Turner
Ed was established as the Supplier Quality Manager at Hill-Rom when I first hired in. I had worked as an Industrial Engineering and Quality Circles Facilitator at another manufacturer, but was cutting my teeth in medical device manufacturing and QA Engineering at Hill-Rom. The system that Ed developed for supplier certification was ahead of its time. It took into account many different facets of the supply chain, ensuring that Hill-Rom's interests were protected by ensuring the suppliers could deliver product, even in the face of challenges. The challenges anticipated ranged from natural disaster to labor disputes. In one case, a supplier experienced a fire at its plant, but was able to begin production in less than a week at a similar plant because it had developed contingency plans required by Ed's certification process. I thank Ed for teaching me the importance of planning ahead and anticipating events in ensuring the continuity of the supply chain.
Dennis Detmer
Ed is a detail oriented employee. I worked with Ed on many projects. Ed was knowledgeable and offered his expertise to the teams. Ed was extremely knowledgeable in his area of expertise, and his participation ensured that the projects and teams finished on time or ahead of schedule. Ed was always available to give advice in regards to Quality and Regulatory issues when needed. Ed provided facts and would provide an opinion when requested. I found Ed to be a highly motivated, and knowledgeable in his field of expertise. If I had the opportunity I would enjoy working with Ed again in a professional capacity. Dennis M. Detmer Technical Product Manager Hill-Rom Co.
Jim Turner
Ed was established as the Supplier Quality Manager at Hill-Rom when I first hired in. I had worked as an Industrial Engineering and Quality Circles Facilitator at another manufacturer, but was cutting my teeth in medical device manufacturing and QA Engineering at Hill-Rom. The system that Ed developed for supplier certification was ahead of its time. It took into account many different facets of the supply chain, ensuring that Hill-Rom's interests were protected by ensuring the suppliers could deliver product, even in the face of challenges. The challenges anticipated ranged from natural disaster to labor disputes. In one case, a supplier experienced a fire at its plant, but was able to begin production in less than a week at a similar plant because it had developed contingency plans required by Ed's certification process. I thank Ed for teaching me the importance of planning ahead and anticipating events in ensuring the continuity of the supply chain.
Credentials
-
Certified Manager of Quality/Organizational Excellence (CMQ/OE)
ASQ - World HeadquartersOct, 1995- Sep, 2024 -
Certified Quality Auditor (CQA)
ASQ - World HeadquartersDec, 1991- Sep, 2024 -
Certified Quality Engineer
ASQ - World HeadquartersDec, 1988- Sep, 2024 -
RAC-US
Regulatory Affairs Certification ProgramDec, 1994- Sep, 2024 -
RAC-US
REGULATORY AFFAIRS CERTIFICATION PROGRAMDec, 1994- Sep, 2024 -
RAPS Member
Regulatory Affairs Certification ProgramSep, 1994- Sep, 2024 -
ASQ Fellow
ASQ - World Headquarters
Experience
-
Prodct
-
United States
-
Business Consulting and Services
-
1 - 100 Employee
-
Advisory Board Member
-
Jan 2023 - Present
Provide support to Prodct Leadership in nurturing early stage companies developing transformative medical devices. Provide support to Prodct Leadership in nurturing early stage companies developing transformative medical devices.
-
-
-
GessNet Safety Engineering
-
Business Consulting and Services
-
1 - 100 Employee
-
Senior Technical Advisor
-
Jan 2023 - Present
Supporting the company mission of Advancing Medical Product Safety Engineering by providing technical advice Supporting the company mission of Advancing Medical Product Safety Engineering by providing technical advice
-
-
-
Pathway for Patient Health
-
United States
-
Manufacturing
-
Adjunct Professor
-
Jan 2023 - Present
Provide courses on Quality Science Education Provide courses on Quality Science Education
-
-
-
-
Principal Consultant
-
May 2003 - Present
Health Care Products Quality and Regulatory Consulting-specializing in Medical Device and Combination Product Risk Management as well as Quality Systems. Participating member of various US and international standards committees Health Care Products Quality and Regulatory Consulting-specializing in Medical Device and Combination Product Risk Management as well as Quality Systems. Participating member of various US and international standards committees
-
-
-
-
Prinicpal, Quality and Regulatory
-
Jan 2006 - Dec 2014
A full service medical device new product development firm. 4MED specializes in assisting companies to create growth through innovative new product development. Three Member/Partners are experts in the fields of Industrial/Communication Design, Electro/Mechanical Engineering and Regulatory Compliance. An out-sourced, central strategic, creative and technical resource for all medical device development needs. A full service medical device new product development firm. 4MED specializes in assisting companies to create growth through innovative new product development. Three Member/Partners are experts in the fields of Industrial/Communication Design, Electro/Mechanical Engineering and Regulatory Compliance. An out-sourced, central strategic, creative and technical resource for all medical device development needs.
-
-
-
Virginia Tech
-
United States
-
Higher Education
-
700 & Above Employee
-
Adjunct Professor
-
Aug 2010 - Aug 2013
Ed Bills has served as an adjunct professor in the Health Product Risk Management graduate program. The program is offered on-line and allows students to concentrate in medical device, pharmaceutical or food science risk management. http://www.iddl.vt.edu/risk/ Ed Bills has served as an adjunct professor in the Health Product Risk Management graduate program. The program is offered on-line and allows students to concentrate in medical device, pharmaceutical or food science risk management. http://www.iddl.vt.edu/risk/
-
-
-
Bilanx Consulting LLC
-
Medical Equipment Manufacturing
-
Principal Consultant
-
May 2002 - Jun 2013
Assist large and small medical device companies in development of risk management processes and quality systems that meet regulatory requirements. We develop systems that support the business requirements without adding unnecessary burdens. The goal is to provide cost-effective systems that can actually provide cost savings in the long term. Assist large and small medical device companies in development of risk management processes and quality systems that meet regulatory requirements. We develop systems that support the business requirements without adding unnecessary burdens. The goal is to provide cost-effective systems that can actually provide cost savings in the long term.
-
-
-
-
Director, Quality Systems and Regulatory Affairs
-
Sep 1994 - May 2003
Responsible for development and maintenance of quality systems at 4 locations of the company, meeting US FDA 21 CFR 820 requirements, ISO 9001 and ISO 13485 requirements. Also responsible for meeting regulatory requirements, including pre-market and post-market documentation. Led company team during inspections by FDA and Notified Bodies.
-
-
Director, Risk Management
-
Mar 2001 - Nov 2001
Additional temporary responsibility until full-time resource could be located. Maintained responsibility as company representative to ISO TC 210/JWG 1 on medical device risk management until retirement in 2003. Continued as independent representative to AAMI/QM/WG04 on medical device risk management to present
-
-
Supplier Quality Manager
-
Apr 1988 - Sep 1994
Responsible for development of supplier quality processes and oversight of approximately 400 companies providing components and services for Hill-Rom's product lines.
-
-
-
-
Manager, Training and Documentation
-
Apr 1982 - Apr 1988
Provided employee and customer training on electronic control systems through staff of ten. Developed training program for employees in quality. As part of program established quality improvement projects in manufacturing and design processes. Assisted in development of supplier quality system, co-presenting this system in IMPRO '87 Juran Institute Conference. Provided employee and customer training on electronic control systems through staff of ten. Developed training program for employees in quality. As part of program established quality improvement projects in manufacturing and design processes. Assisted in development of supplier quality system, co-presenting this system in IMPRO '87 Juran Institute Conference.
-
-
-
-
Assistant Director and Instructor
-
Aug 1973 - Apr 1982
Electronics Instructor while completing Masters degree; promoted to Program Supervisor for four campuses and later to Assistant Director of Scarlet Oaks site. Held Ohio Education Certificates for Electronics Instructor; Curriculum Supervisor; and Vocational Director. Completed Ohio Vocational Internship through Kent State University. Electronics Instructor while completing Masters degree; promoted to Program Supervisor for four campuses and later to Assistant Director of Scarlet Oaks site. Held Ohio Education Certificates for Electronics Instructor; Curriculum Supervisor; and Vocational Director. Completed Ohio Vocational Internship through Kent State University.
-
-
-
-
Submarine Navigation Shift Supervisor and Lead Inertial Navigation Technician ET1(SS)
-
Sep 1965 - Dec 1969
Installed and tested submarine navigation system as Electronics Technician Navigation during construction of the Vallejo and after commissioning participated in missile launch off Cape Canaveral, FL, transited Panama Canal en route to new homeport of Pearl Harbor. Was Shift Supervisor of Navigation Center during 5 ballistic missile patrols conducted from Guam, responsible for operation of system providing details navigation information for ships systems, and getting frequent exacting position fixes at all times while on watch. Operated highly classified systems requiring security clearances, operating navigation systems during critical phases of submarine operations to obtain precise position and heading information using star tracking equipment along with other classified precision navigation systems.
-
-
-
US Navy
-
United States
-
Armed Forces
-
700 & Above Employee
-
US Navy Veteran, Submarine Qualified
-
Nov 1962 - Dec 1969
-
-
-
-
Qualified in Submarines, ETN3(SS)
-
Mar 1964 - Dec 1964
Performed numerous electronics, sonar, radar. and other duties as required, aboard a US diesel submarine while qualifying. The ship trained SEALS, UDT, and Force Recon Marines in the Virgin Islands and Puerto Rico on Submarine Special Operations Performed numerous electronics, sonar, radar. and other duties as required, aboard a US diesel submarine while qualifying. The ship trained SEALS, UDT, and Force Recon Marines in the Virgin Islands and Puerto Rico on Submarine Special Operations
-
-
Education
-
1973 - 1975
University of Cincinnati
Master of Education - MEd, Education Administration -
1970 - 1973
University of Cincinnati
BS, Science Education -
US Navy Veteran
Electronics
Community
