Manager Quality
Resume:
Title:Don Swanston
**********@*****.***
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Name: Don Swanston
Resume Details
Military Service: None
Security Clearance: None
Willing to Relocate: Yes
Acceptable Travel: Up to 30%
Career Level: Management (Manager / Director of staff)
Years of Experience: 20+ Years
Last Updated: 5/21/2010
Highlighted Skills:
Resume Summary:
Resume:
DONALD G. SWANSTON
26680 Camino Seco
~ Temecula, California 92590
**********@*****.***
SENIOR QUALITY EXECUTIVE
Regulatory Compliance ~ Continuous Quality Improvement ~ Quality Systems Integration
Seasoned, accomplished Quality Director with extensive experience in the medical device
industry. Proven track record includes implementation and integration of global quality
programs as well as continuous compliance with all FDA, ISO, and other regulations.
Proactive, results-oriented leader skilled in development and manufacture of medical
devices. Demonstrated success streamlining quality systems to improve productivity, reduce
budgets, and ensure optimal results for the release of new products to market. Core skills
areas include:
Quality System Regulations ISO Certification Project & Process Management
Product Performance Reporting Risk Management Lean Design & Simplifications
Training & Education Design Controls Corrective & Preventive Actions
CAREER ACCOMPLISHMENTS
ABBOTT VASCULAR, INC
. 2006Present
Developed and successfully initiated a worldwide program to integrate the company s
quality systems across ten manufacturing/distribution sites by 2011; successful
integration of five sites completed currently.
Devised and simplified robust quality systems that earned high marks with no business
interruption or critical findings after completing numerous external and internal
compliance audits.
Launched a global program that doubled CAPA content scores, reduced budget by 24%, and
certified 380 investigators; earned division recognition as the performance leader by
executive management as a result.
GUIDANT, INC
. 19942006
Selected by peers and executive management to receive a Circle of Champions award as
one of the top ten managers in the corporation.
Successfully led a cross-functional team in implementing the FDA s Quality Systems
Regulations two months ahead of the agency s effective date.
Implemented and passed ISO 13485:2003 certification ensuring the company s continued
adherence to all medical device standards and regulations.
Directed the design and development of an atherectomy system to treat in-stent
restenosis while supporting two clinical trials; the product was approved and earned
favorable reviews by customers.
Enhanced productivity by implementing Lean process improvements for catheter
manufacturing lines; increased catheter assembly rate by 20%.
ADVANCED CARDIOVASCULAR SYSTEMS, INC
. 19891994
Developed and released for distribution a top-selling dilatation catheter product six
weeks ahead of schedule.
Reduced costs by 30% and consolidated product lines that improved efficiency as a
result of streamlining the design of a coronary dilatation catheter.
PROFESSIONAL EXPERIENCE
ABBOTT VASCULAR, INC
., Temecula, California 2006Present
Vascular care provider offering vessel closure, endovascular, and coronary products;
division of Abbott Laboratories.
Director
Global Quality Systems (2008-Present)
Spearheads the global, company-wide implementation, integration, and maintenance of
quality systems across ten sites in four countries.
Oversees support aspects of the quality program including document control, change
management, corrective and preventive actions, and organizational training.
Plays an integral role as part of a collaborative team to improve Abbott s efficiency
via integration of the supply network and implementation of Lean and Six Sigma practices
across sites.
DONALD G. SWANSTON Page Two
PROFESSIONAL EXPERIENCE (Continued)
Director
Global Quality Systems (Continued)
Upgraded three business systems (Plateau, AssurX, and ViewPoint) that were recognized
as best in class and later expanded to other Abbott sites.
Eliminated hundreds of unnecessary documents and substantially reduced content by 50%
as a result of initiating a quality systems simplification program.
Site Quality Head (2006-2008)
Ensured the quality, reliability, and compliance of 12 product lines as head of a site
management team for three facilities.
Identified and resolved a design-related product issue, which included communicating
with customers and the FDA as part of directing correction and removal activities.
Enabled the market release of three new catheter products by meeting all design control
deliverables.
GUIDANT, INC
., Temecula, California 19952006Designer, developer
and manufacturer of cardiovascular medical products.
Director, Quality Assurance, Compliance and Product Performance (2005-2006)
Maintained responsibility for the division s executive management reviews and product
performance reporting.
Served as primary liaison between staff and external agencies during regulatory agency
inspections.
Supported business growth by expanding product performance and compliance groups from
one to three managers and from three to seven analysts.
Orchestrated ISO 13485:2003 implementation to secure the certificate of conformity for
international distribution.
Laboratory Manager
(2002-2005)
Oversaw quality and compliance for calibration, packaging engineering, and reliability
engineering labs.
Improved laboratory performance metrics and resolved compliance issues that resulted in
executive management s best in class designation for the reliability engineering
laboratory.
Improved the data integrity of in vitro bench testing by implementing a paperless
Applied Biosystems SQL*LIMS system, which included a report writer application to simplify
regulatory submissions.
Substantially reduced direct testing labor for new products by 55% while ensuring
successful completion of 600 test requests and 8,000 test samples on average per month.
Quality Manager
(2000-2002 & 1995-1998)
Directed all aspects of quality engineering support and inspections for the guiding
catheter, accessory, and atherectomy product lines.
Manager, Research and Development (1998-2000)
Led an improvement initiative for a coronary dilatation catheter that resulted in the
product being released to market ahead of schedule and positive feedback from physicians.
Oversaw product development teams and directed the implementation of three new products
with all design control deliverables completed on time and all three products still
currently successful in the market.
ADVANCED CARDIOVASCULAR SYSTEMS, INC
., Temecula, California 19891994Designer, developer
and manufacturer of cardiovascular medical products.
Manager, Manufacturing Engineering (1993-1995)
Oversaw manufacturing implementations for the company s new products.
EDUCATION
UNIVERSITY OF SOUTHERN CALIFORNIA,
Master of Science in System Management
CALIFORNIA STATE UNIVERSITY,
Bachelor of Science in Industrial Technology
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