Cindi Kisiel-Smith Email & Phone Number

Working with a variety of OTC and Cosmetic Manufacturers

Greater Miami Area

Working on a supplier quality remediation with a manufacturer of a life sustaining implantable medical device.

Greater Chicago Area

Working on a supplier quality program remediation with a leading Generic drug/ Medical Device manufacturer

Providing Quality Assurance and Regulatory Compliance consulting to the medical device and IVD industry. Recent projects include training on introductory design control; Quality System gap assessments; and Quality System SOP writing.

Working on a large scale remediation project with a leading cardiovascular medical device manufacturer

Project lead for an Asia wide Quality System remediation project for a medical device manufacturer.Responsible for providing project leadership for three facilities in Japan and China; developing processes; drafting multi-level procedures; performing training on areas such as audit administration, CAPA, management review, and analysis of data; performing.

Provided Quality department leadership for a multi-site company manufacturing transfusion related biologic in vitro diagnostics. Emphasized training and development of departmental employees to strengthen the overall Quality function. Championed continuous improvement utilizing LEAN and Six Sigma methodologies.

Responsible for Quality and Regulatory leadership of a facility manufacturing Class I and Class II in vitro diagnostics. Ensured compliance with all FDA and ISO requirements by implementing and maintaining quality systems, policies and procedures.