• QSR
• Compliance
• Quality Systems
• FDA Inspections
• Warning Letters

Sue Jacobs is the founder and Principal Consultant for QMS Consulting, Inc., a quality management consulting firm providing consulting and educational services to FDA regulated medical device industry. Ms. Jacobs utilizes more than 20 years of experience in the medical device industry and specializes in Quality System compliance to US FDA and ISO regulatory requirements for medical devices assisting manufacturers in developing, implementing, and maintaining compliant quality system programs.

Ms. Jacobs has spent considerable time in developing and re-engineering CAPA systems for medical device firms. In addition, Ms. Jacobs conducts assessments and presents various in-house training courses including US FDA Medical Device Quality System requirements (GMP), CAPA (Corrective and Preventive Action), FDA Inspection Readiness, and ISO training. She has served as an FDA Expert Witness and is a recognized Subject Matter Expert to the medical device investors of Standard and Poor s. Prior to QMS Consulting, Inc. she was a Quality System Consultant with Medical Device Consultants, Inc. (MDCI) and served as Manager of Quality Assurance for Siemens Medical Systems, Nuclear Medicine Group. Sue is a past Chair of ASQ Biomedical Division 2002-04 and also served on the ASQ Board of Directors, 2004-06.

She is a a senior member of ASQ, a member of the RAPS, faculty member for AAMI s GMP and Industry Practice Course and a frequent speaker for AdvaMed MTLI, Thompson Interactive, Canon Communications and Management Forum, Ltd.

Request that travel expenses be covered.