Quality Assurance Medical Device
Resume:
SUSAN M DUENSING
*************@*****.*** (***)
www.linkedin.com/in/sueduensing
SUMMARY
Director, Quality/Regulatory with extensive and versatile experience in the Pharmaceutical, Biotech and Medical Device
industries on a global scale. Expertise includes Quality Assurance, Regulatory Affairs, Clinical Services and
Manufacturing responsibilities related to large volume parenterals, small volume injectables, Class I, II, III implantable
devices, hardware/disposable products and blood and blood components. QA responsibilities include ISO 13485, 9001,
FDA QSR, MDD, Quality System Assessments, CAPA programs, Design Control/Product Development and Document
Control. Regulatory includes ISO/CE Marking Certification, Regulatory Submissions, Clinical Trial Program and Medical
Device Reporting (MDRs).
WORK EXPERIENCE
AMERICAN RED CROSS, Charlotte, NC 2001 – 2014
Sr. Director of Clinical Services, Southeast (8 regions) 2010 – 2014
Managed the growth, maintenance and compliance of the Clinical Services operations in the Southeast Division (SED).
• Growth of clinical services for new therapeutic procedure for Stage IV Prostate Cancer performed within Red Cross
Apheresis Therapeutic (THAP) centers
• Established and opened16 THAP centers in the following geographies; Alabama, Georgia, North Carolina, Puerto
Rico, South Carolina, Tennessee, and Virginia
• Grew revenue for Prostate Cancer procedures from 373 procedures in 2011 to 1326 in 2012, resulting in a growth rate
of 255.5%
• Established the benefit of performing Clinical Trials for new therapies using therapeutic apheresis as a method of
treatment by pursuing companies interested in clinical trial sites outside the normal hospital setting. SED is now the
leading clinical site of seven divisions in the American Red Cross system for new therapies including Phase II and
(FDA fast track) Phase III clinical trials
Sr. Director of Quality, Southeast (5 regions) 2001 - 2010
Regional Quality Director
Led compliance activities related to cGMP Guidelines, FDA regulations, AABB standards and other applicable
requirements. The Southeast Division is the largest of eight divisions in the American Red Cross with blood collections of
approximately one million units annually. This resulted in approximately 3 million manufactured and distributed products
per year. The Southeast Division includes four major manufacturing facilities and 36 fixed site collection locations.
• Senior Leadership oversight of the Quality Systems implementation and compliance status of five regions
(Alabama/Gulf Coast, Carolinas, Puerto Rico, South Carolina and Southern Region)
• Managed five Regional Quality Directors, a Problem Management Director, and a Senior PM Analyst. These directors
in turn are responsible for over 100 QA and PM staff
• Member of QA Process Council at Biomedical Headquarters in Washington DC for QA policy decisions
• Led the Southeast Division’s Quality Compliance & Oversight Committee for review and improvement of key
Quality Indicators in the operation
• Worked in partnership with the Southeast Division Vice President (DVP) as a model of leadership that includes
quality, compliance and financial health
• Responsible for establishing, meeting and maintaining goals that aligned with the strategic vision of the organization
• Successfully integrated the Quality of the Carolinas and South Carolina Regions into one team in order to
maximize efficiencies and provide additional opportunities for staff
• Successfully managed large operation in a Consent Decree environment
• Selected as one of two Regional Quality Directors (of 36) to develop and author the new Problem Management
Process (SmartCAPA) at National Headquarters (BHQ)
• Hosted FDA inspections, ARC corporate audits, AABB Assessments and audits/inspections by other agencies
Susan Duensing Page 2
BAXTER HEALTHCARE CORPORATION, Round Lake, IL 1992 - 1999
CE Marking Manager (Fenwal Division)
Global Quality Assurance Manager (Renal Division)
Managed the Division’s compliance to ISO 9001 and the European Medical Device Directive, 93/42/EEC
• Managed the European Regulatory Affairs group in Nivelles, Belgium
• Supported all new product development activities for Division’s disposables, hardware, blood components products
• Authored all European Regulatory submissions (CE Applications) for Division’s disposables, hardware, blood
components products
• Liaison between USA and Europe for business units and assigned Regulatory managers
• Successfully developed and implemented ISO/Regulatory (CE Marking) strategy for Division in order to prevent loss
of sales
• Developed and coordinated international labeling group and successfully implemented the use of multi-lingual
languages (12 languages) within one year
• Worked successfully with European colleagues to establish excellent working relationship with Notified Body (TÜV
Product Service)
• Developed and implemented Renal Division’s European Quality Systems; changing from individual country
Quality Systems to one EU Quality System (new product review, clinical studies program, document control, multi-
plant approval of product changes)
• Managed the supplier quality program and expanded from domestic to global program
SURGITEK, BRITSTOL-MYERS SQUIBB CORP, Racine, WI 1987 - 1992
Quality Assurance Manager:
Responsible for the company’s compliance to cGMP guidelines and FDA Regulations for Class I, II and III medical
devices, including ureteral stents, breast and penile implants in two manufacturing locations
• Established design control program for new product development
• Sterilization validation (EO, steam, and gamma)
• Biocompatibility testing requirements for new products/materials
• Document/label control with associated record retention area
• GMP compliance (internal/external assessment program)
• Opened return goods lab (technical evaluation of all opened/explanted product)
• Developed company program for new MDR requirement (filing of Medical Device Reports with FDA)
• Responsible for $187,000 cost reduction by standardizing sterilization procedures and $200,000 for implementation
of batch system
ARMOUR PHARMACEUTICAL Section Head, Parenteral Manufacturing
ABBOTT LABORATORIES Manufacturing Supervisor
EDUCATION
CLEMSON UNIVERSITY BS BIOCHEMISTRY
PROFESSIONAL MEMBERSHIPS
REGULATORY AFFAIRS PROFESSIONAL SOCIETY (RAPS)
ASSOCIATION OF QUALITY CONTROL (ASQC)
AMERICAN ASSOCIATION OF BLOOD BANKING (AABB)
AMERICAN SOCIETY FOR APHERESIS (ASFA)
CERTIFICATION
ISO 9001 LEAD EXAMINER CERTIFICATION
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