Cindi Kisiel-Smith

Cindi Kisiel-Smith Email and Phone Number

Principal Consultant at Cynthia J Kisiel-Smith, Inc @ QualityHub, Inc.
orlando, florida, united states
Cindi Kisiel-Smith's Location
Lilburn, Georgia, United States, United States
Cindi Kisiel-Smith's Contact Details

Cindi Kisiel-Smith personal email

n/a
About Cindi Kisiel-Smith

A Quality Assurance/Regulatory Compliance professional with greater than 15 years experience in pharmaceuticals, medical devices, and biologic in vitro diagnostics. Skilled in the development and maintenance of Quality systems. Well versed in FDA audit management and resolving compliance issues.Specialties: RAC certified, Biologics, Microbiology, Environmental Monitoring, Test Method and Process Validation, cGMP, Internal Quality Auditing, SOP writing,Six Sigma Champion, Compliance, Regulatory, QA/QC, Leadership, Management skills, Training

Cindi Kisiel-Smith's Current Company Details
QualityHub, Inc.

Qualityhub, Inc.

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Principal Consultant at Cynthia J Kisiel-Smith, Inc
orlando, florida, united states
Website:
qualityhub.com
Employees:
14
Cindi Kisiel-Smith Work Experience Details
  • Cynthia J Kisiel-Smith, Inc
    Principal Consultant
    Cynthia J Kisiel-Smith, Inc Jan 2018 - Present
    Working with a variety of OTC and Cosmetic Manufacturers
  • Cynthia J Kisiel-Smith, Inc
    Principal Consultant
    Cynthia J Kisiel-Smith, Inc Oct 2014 - Present
    Greater Miami Area
    Working on a supplier quality remediation with a manufacturer of a life sustaining implantable medical device.
  • Cynthia J. Kisiel-Smith, Inc.
    Principal Consultant
    Cynthia J. Kisiel-Smith, Inc. Nov 2012 - Present
    Greater Chicago Area
    Working on a supplier quality program remediation with a leading Generic drug/ Medical Device manufacturer
  • Cynthia J. Kisiel-Smith, Inc.
    Principal
    Cynthia J. Kisiel-Smith, Inc. Jul 2010 - Present
    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.
  • Qualityhub, Inc.
    Senior Consultant
    Qualityhub, Inc. Oct 2010 - Present
    Working on a large scale remediation project with a leading cardiovascular medical device manufacturer
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  • Ken Block Consulting
    Quality System Manager Lead
    Ken Block Consulting Oct 2009 - Oct 2010
    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 Quality System audits across all Asia facilities.
  • Immucor, Inc.
    Vp Ww Quality
    Immucor, Inc. Jul 2005 - Feb 2009
    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.
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  • Bd Diagnostic Systems
    Qa/Ra Manager
    Bd Diagnostic Systems Apr 2000 - Jul 2005
    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.
  • Abbott Laboratories
    Ra Specialist; Group Leader; Aqa Supervisor
    Abbott Laboratories Sep 1990 - Apr 2000
    View

Cindi Kisiel-Smith Skills

Sop Quality Assurance Compliance Life Sciences Six Sigma Microbiology Environmental Monitoring Quality Systems Process Validation Fda Capa Gmp Validation Medical Devices Design Control Quality Auditing Quality Management Qsr Document Management Regulatory Requirements Process Improvement Validations Quality System V&v 21 Cfr Part 11 Pharmaceutical Industry Iso 13485 Iso Lifesciences Continuous Improvement Manufacturing

Cindi Kisiel-Smith Education Details

Frequently Asked Questions about Cindi Kisiel-Smith

What company does Cindi Kisiel-Smith work for?

Cindi Kisiel-Smith works for Qualityhub, Inc.

What is Cindi Kisiel-Smith's role at the current company?

Cindi Kisiel-Smith's current role is Principal Consultant at Cynthia J Kisiel-Smith, Inc.

What is Cindi Kisiel-Smith's email address?

Cindi Kisiel-Smith's email address is ck****@****hub.com

What schools did Cindi Kisiel-Smith attend?

Cindi Kisiel-Smith attended Texas Tech University.

What skills is Cindi Kisiel-Smith known for?

Cindi Kisiel-Smith has skills like Sop, Quality Assurance, Compliance, Life Sciences, Six Sigma, Microbiology, Environmental Monitoring, Quality Systems, Process Validation, Fda, Capa, Gmp.

Who are Cindi Kisiel-Smith's colleagues?

Cindi Kisiel-Smith's colleagues are Rebecca Fuller, Darla Delph, Joel Paradis, Cherie Wells.

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