Cindi Kisiel-Smith

Cindi Kisiel-Smith has a diverse and extensive work experience in the medical device and in vitro diagnostics industry. Cindi is currently the Principal Consultant at Cynthia J Kisiel-Smith, Inc, a role they have held since 2014. Their responsibilities include providing quality assurance and regulatory compliance consulting. Prior to this, they were a Senior Consultant at QualityHub, Inc., starting in 2010.

From 2009 to 2010, they worked at Ken Block Consulting as a Quality System Manager Lead with a focus on a Quality System remediation project for a medical device manufacturer in Asia.

Cindi also has experience at Immucor, Inc. where they were the VP of WW Quality from 2005 to 2009 and emphasized training and development of departmental employees while implementing LEAN and Six Sigma methodologies for continuous improvement.

Before that, they were the QA/RA Manager at BD Diagnostic Systems from 2000 to 2005, responsible for ensuring compliance with FDA and ISO requirements.

Cindi started their career at Abbott Laboratories in 1990, where they held various roles including RA Specialist, Group Leader, and AQA Supervisor until 2000.

Cindi Kisiel-Smith obtained their Bachelor of Science degree in Microbiology from Texas Tech University, where they studied from 1983 to 1987.