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STRENGTHS/KNOWLEDGE/KEY SKILLS
PROFESSIONAL HISTORY
Sunquest Information Systems, Tucson, AZ.
Patient Safety Analyst (2003 – 2010)
Key contributor in assembling and submitting post-market complaint
handling, medical device classification, product approvals, and audit
responses to the Food and Drug Administration.
Collect and report metrics on compliance efforts.
Communicate appropriate information of all product safety issues to
internal and external clients for multiple product lines.
Review and make recommendations for risk assessment and
minimization.
Ensure company processes and procedures fulfill all requirements
regarding 21 CFR 803 Medical Device Reporting, 21 CFR 806 Medical
Device Reports of Corrections and Removals, ISO 14971 Application of
Risk Management to Medical Devices and ISO 13485 Medical Devices
Quality Management Systems.
Conducted random inspections, full audits and held meetings to assure
compliance.
Senior Development Analyst (2000 – 2003)
Elicited requirements using multiple methods, including: interviews,
surveys, site visits, use case scenarios, workflow analysis, and/or
user input.
Derived and documented requirement specifications for software
development projects and products.
Successfully utilized analytical skills to critically evaluate
information gathered from multiple sources to reconcile conflicts, to
decompose high-level information into details, to abstract up from
low-level information to a more general understanding, to determine
user needs based upon user requests, and to distinguish solutions
based upon requirements.
Provided input to the development of prototypes to ensure product
met requirements.
CHARLES A. HAWKINS
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EDUCATION
PROFESSIONAL AFFILIATIONS
American Society of Clinical Pathologists: MT (ASCP) Certified, Board of
Registry Number 159364.