CHARLES ANSON HAWKINS

 8951 East Calle Playa  Tucson, AZ 85715  (520) 731-9602 

stiekins@cox.net

HEALTH CARE PROFESSIONAL

Medical Technologist with expertise in LIS Management,
Quality Validation, Requirements Engineering and Regulatory
Affairs

STRENGTHS/KNOWLEDGE/KEY SKILLS

 Strong aptitude for training technical Effective management of multiple

and non- projects
technical materials to diverse groups Excellent Leadership &
 Strong analytical skills Communication Skills
 Expertise working with multi-  Exercise Excellent Judgment
cultural teams  Quick to Learn New Systems &
 Proven leadership in cross-team Technology
projects  Ability to relocate
 Strong Research and Writing 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
PAGE 2

 Performed peer reviews of work products derived from requirement

specifications.
 Managed changes to baseline requirements through effective
application of change control processes and tools.

Quality Control Manager (1995 – 2000)

 Managed software testing for multiple product lines using
automated tools and accepted software test methodology.
 Reviewed functional requirements, testing evidence and
documentation for program changes and enhancements.
 Successfully conducted multiple internal Business Management
System audits and recommended corrective and preventative
actions.
 Managed a team consisting of thirteen professionals, including
responsibility for: hiring, scheduling, and performance evaluations.
 Ensured Transfusion and Donor software requirements met FDA and
AABB compliance requirements.

Transfusion and Donor Implementation Account Manager (1991 –

1995)
 Successfully managed an average of twenty-five concurrent client
installations.
  Managed team consisting of six installation analysts.
 Participated in management seminars to increase leadership skills.

Installation Analyst (1989 – 1991)

 Managed the overall installation process for assigned accounts,
including responsibility for: training clients in file maintenance and
system functionality for multiple laboratory modules, HIS, Billing,
Instrument interface definitions, system monitoring utilities, and
troubleshooting techniques.
 Reviewed workflow at the client site and recommended
policy/procedure changes based on standardized governing
regulations.
 Installed three Health Care facilities with the Sunquest Laboratory
product lines successfully.

Brigham and Women’s Hospital, Boston, MA

Laboratory Supervisor (1987 - 1989)
 Successfully managed all areas of the clinical hospital laboratory,
including; implementation, training and management of new
laboratory information system; monitoring and providing continuing
education for staff members; writing and maintaining procedures;
monitoring and managing department quality control.
 Managed personnel; prepared budget; monitored and dealt with
department financial issues; participated in hospital committees.
 Assured compliance with CAP, JCAHO and AABB standards and
requirements.
CHARLES A. HAWKINS
PAGE 3

 Conducted random inspections, full audits and held meetings to

assure compliance.

EDUCATION

Bachelor of Science, Medical Technology; Northeastern University, Boston,

MA

PROFESSIONAL AFFILIATIONS
 American Society of Clinical Pathologists: MT (ASCP) Certified, Board of
Registry Number 159364.

 National Certification Agency, NCA Certified.

 Internal Quality Auditing Certified: Business Systems Architects,
Certificate Number I0496-04