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SUMMARY -
John C Hoffman
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Creative and responsible professional with extensive
worldwide V.P./Director level experience. Expertise in
quality assurance and management and medical device
regulatory affairs. Other areas of proficiency include
all FDA regulations, ISO 9000/13485
international quality standards, sterilization, product
safety and liability, SEI Capability Maturity Model, and
client satisfaction. Expertise in a wide range of
products, including IVD, biologicals, pharmaceuticals, software, instrumentation,
electronics and disposables. Effectively implemented and
maintained compliance with regulations and standards
through training and awareness initiatives. Utilized
team building programs and strong working relations with
the FDA and standards and industry associations. |
SKILLS
& SPECIAL QUALIFICATIONS
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Almost thirty years of Medical Device, Pharmaceutical
and Biologics Quality and Regulatory experience,
including twenty years at the Director/Vice
President level and over eight years in consulting.
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Experienced in start-ups and re-engineering quality
systems.
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Over fifteen years experience in medical software and
information systems, including GxP software, process
control systems and software products regulated by
the FDA. Expertise in all phases of the software
development life-cycle, design controls, hazard
analysis, validation, installation, support and PMAA, 510(k),
pre-IDE and de novo
submissions.
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Extensive, broad knowledge of US FDA quality &
regulatory body regulations.
ACCOMPLISHMENTS
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Established or re-engineered Good Manufacturing
Practices/Quality Systems Regulations programs at
several medical device manufacturers, with no major
compliance deviations found on subsequent
inspections.
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Reversed serious FDA compliance problems and avoided
potential legal sanctions for multi-facility
international manufacturer of sterile disposables
and reusable items.
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Reduced the number of software product safety
defects delivered to clients by 75% in one year
through implementing proactive safety awareness,
design hazard analysis and process improvement
programs.
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Achieved 50% reduction in healthcare informatics
software development cycle time while reducing
delivered defects by 30% through implementation of SEI CMM. Improved SEI CMM indicators from level 1 to
level 3 in a two year time frame.
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Increased client satisfaction levels in all
categories by over 25% over a two year period
through implementation of Motorola quality
initiatives.
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Significantly reduced costs and cycle time while
improving quality of both ethylene oxide and
radiation sterilization processes through cycle and
process re-engineering and packaging improvements.
TRAINING
FDA, Johnson & Johnson, Motorola, Trade Associations -
Ongoing seminars on FDA regulations, QSR, QSIT, GxP,
HIPAA, risk management, document and change control
management, international standards, product
safety/liability, software process (SEI, IEEE), quality
management, Six Sigma, process mapping, electronic
data/signatures (21CFR11), team building, leadership and
sterilization.
PROFESSIONAL AFFILIATIONS
AAMI, ASQA, RAPS, AABB,
AdvaMed, CHIMS, HIMMS, WEDI, Center
for Software Excellence (Director 1992-95), Florida
Medical Device Association (Director 1984-85), Arizona
Quality Alliance, Arizona Software Association, Arizona
Bioindustry Association, Bioindustry Organization of
Southern Arizona.
AWARDS AND HONORS
Special Commissioner’s Citation – FDA – 1997
Leadership Award – Center for Software Excellence - 1994
EDUCATION
B.A. in Economics, Northwestern University - 1974
Certified ISO 9000 Lead Auditor - 1995
AAMI Certificate of Achievement - GMP Requirements and
Industry Practice - 1997
AAMI Certificate of Achievement - Design Controls -
2006
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