Christie Cianci

Sr. Quality Systems Consultant

Christie has over twenty years of experience, including certification, in quality assurance and regulatory compliance in the biomedical and medical device industries. She has vast experience in implementing and maintaining all aspects of FDA/QSR as well as ISO compliant Quality Systems, including design, documentation, corrective and preventive actions, validation, quality training, complaint handling, internal and external audits, supplier management, and continuous improvement. She has successfully dealt with FDA inspections, audit responses, and ISO certification programs. She has most recently consulted with major diagnostic companies on consent decree remediation, and quality system improvements. She also has experience on executive business teams in designing and leading strategic business initiatives, developing technical organizations, and implementing lean/team based manufacturing.

EXPERIENCE:

• Contract Acting Global CAPA Engineer for major Medical Device Manufacturer of Cardiac stents and catheters. Provided Documentation review and coaching to CAPA owners and management.
• Participated as member of the third party consultant team at Abbott Laboratories to implement new quality systems and enable Abbott’s diagnostic division to be found in substantial compliance in the successful response to FDA consent decree. Activities included audits, documentation review, change control, design control and team mentoring in CAPA investigation and closure.
• Conducted gap assessment for a software development company and provided guidance in implementing quality system documentation and improvements.
• As Director of Quality Assurance and Regulatory Compliance for two leading diagnostics manufacturers, led efforts to implement ISO 9001/13485 and QSR compliance quality systems and implementation.
• As member of site and corporate management teams planned functional organizational needs, budgeting and strategic planning, facilitated site consolidations, re-engineering of key business processes, implementation of lean manufacturing and team based organizations, and design and implementation of corporate wide quality systems and initiatives.
• Led all aspects of Quality Assurance and QC functions for IVD manufacturing operations including material and product testing and release, document control, new product transfer, validation, audit, complaint investigation, customer notifications and recalls, CAPA and training.
• Led Regulatory Affairs function in successful product 510K and PMA submissions, facility registrations, and global product licensing and approvals. Provided regulatory guidance for FDA, DEA, EPA and other regional, national and global regulation compliance.
• Led IVD Directive team in implementation of CE marking of product line for international distribution.
• Led training team in design and development of a comprehensive quality training program, and modules culminating in a 2 day quality congress for Syva Company.

POSITIONS HELD:

• Sr. Quality Consultant C&C Consulting
• Director of Quality/Regulatory Dade Behring Corporation
• Director of Quality Operations Bayer Diagnostic Corporation
• Quality Manager Meloy Laboratories
• Immunodiagnostics Sales CalbioChem Behring Corporation
• Nuclear Medicine Technologist/Supr Georgetown University

EDUCATION:

•  B.S Biological Science/Education Iowa State University

CERTIFICATIONS / TRAINING:

Certified Regulatory Affairs (R.A.C.), Regulatory Affairs Professional Society

Certified Quality Manager (C.Q. M.), American Society Quality

Certified Quality Auditor (C.Q.A), American Society Quality

Lead Auditor training, Excel (RAB Certified Course)

Problem Solving/Decision Making/6 Sigma

Project Management