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Denise A.

Columbia, TN 38401
(727) 452-4796

A highly ethical and productive administrative professional with over 9 years of
experience in performing various roles within the Quality & Regulatory divisions of
medical device manufacturing companies. Eleven years experience managing a
warehouse distribution center.

Meticulous organizational and follow-up skills, vigilant adherence to company
policies and procedures, genuine customer service focus, ability to make
independent decisions with minimum oversight, strong oral and written
communication skills, prioritizes and manages multiple projects/tasks, adaptable
and flexible with sound problem solving skills. Familiar with a wide variety of
medical devices, anatomical and physiological terminology. Proven competency in
the FDA Quality System and Medical Device Reporting regulations (21 CFR 803 and
21 CFR 820.).


Validant Consulting, Inc.

Senior Post Market Surveillance Specialist-Consultant, Boston Scientific
High volume preparation of MedWatch reports for the Urology and Endoscopy
Departments. Drafting of the initial and supplemental MedWatch reports utilizing
CSubmitter, eMDR and 3500A forms. Designated MDR approver for the Endoscopy
Department. Mentoring product analyst’s in MDR coding and drafting. Written
correspondence to end users providing device analysis report and correct device
usage details. Review complaint files in TrackWise for accuracy, create appropriate
rework assignments and complaint file closures.

ConMed Linvatec, Largo, FL

Medical Device Reporting Specialist
Processing of medical device complaints for determination of MDR reportability.
Review of evaluation findings, appropriate failure mode coding and communication
with surgical staff to acquire event details. Communicate with technical support
staff, Quality Engineers, R&D and lab personnel. Initiate corrective action requests,
stock audit requests and review of device history records. Written non-reportable
rationales, decision trees, filing of initial and follow-up MedWatch, Baseline,
Vigilance, Foreign Adverse Event, Canadian and TGA reports. Written customer
correspondence. Training of new hires. 2nd review of reports and rationales.
Products include powered instruments, various disposable and reusable accessories,

ablation devices, metal and bioabsorbable anchor systems, suture passing
instrumentation, positioning devices, fracture fixation devices, tissue repair
systems, arthroscopic fluid management and arthroscopic video systems.

Intellect Technical Solutions, Clearwater, FL

Product Surveillance Specialist II-Consultant, Baxter Healthcare
Processing of medical device complaints for MDR reportability. Support the
complaint handling activities for complaints requiring in-depth or more complex
investigations with the
appropriate senior level associate. For basic or low risk complaints, review and
evaluate, perform risk assessments, MDR determination, problem and component
coding, prepare a
written summary of investigation from receipt of the complaint through justification
for closure according to quality system regulations. Product families included
peritoneal dialysis and hemodialysis products and devices.
 Processed and closed over 5,000 complaints resulting in a confidential bonus
 Training of new hires
 Outstanding Performance Award 2006 by Intellect Technical Solutions

Bovie Medical Corporation, St. Petersburg, FL

Customer Service Representative (2000-2001)
Incoming call center, order processing, invoicing, set-up accounts, complaint
resolution, order tracking, expediting, product presentation and written
correspondence. Assist Regulatory Affairs in product recall notifications and
Quality Specialist/Complaints Administrator (2001-2003)
Perform inspection and release of incoming product from the ETO sterilization
facility. Lead quarterly product performance and package testing. Processing
medical device complaints, coding, risk assessments, CAPA & FCA coordination, FDA
Medwatch initial and follow-up reporting, returned product inspection, root cause
determination. Product Recalls. Products include electrosurgical units, cauteries,
nerve stimulator/locator, electrodes, ablators and medical lights.
 Voluntarily assumed the plant manager’s responsibility to write and review
annual supplier contracts and to create monthly supplier performance reports
for management review.
 Promoted to Supervisor of Documentation & Quality Records.
Documentation Department Supervisor/Complaints Administrator
Train and supervise documentation department personnel. Control of external
documents, new product proposals, SOP’s, change control process. Processing all
medical device complaints, coding, risk assessments, CAPA & FCA coordination,
initial and follow-up Medwatch reporting, product inspection and evaluation, root
cause determinations. Designated training coordinator. New vendor contracts and
contract renewals and monthly reporting of vendor performance to management.

Raytron Enterprises, Inc., St. Petersburg, FL
Warehouse Manager
Recruit, train, and supervise warehouse and customer service personnel. Inventory
vendor and customer account set-up and maintenance. Inventory control, sales,
receiving, delivery schedules, budget development and administration. Inventory
purchasing, pricing, equipment maintenance, accounts payable, created and
implement product promotions.
 Selected to serve as a member of the Franchisee Review Board, with
responsibility to interview and select potential franchisees, based upon their
business success potential
 Reduced inventory overages/shortages to less than $100 annually.
 Increased sales/profits to the highest level in company history

Mindis Metals, Inc., Atlanta, GA

Office Manager
Cash withdrawal, deposits and record keeping. Grading and pricing of alloy and non-
alloy metals, purchasing metals for cash from general public and large commercial
accounts. Customer service, employee time sheets, scheduling of common carriers
to pick up and deliver materials to processing plants, operation of commercial truck
scales and maintaining OSHA logs. Assisted local law enforcement in the seizure of
stolen materials.

Raytron Enterprises, Inc. Pensacola, FL

Office Manager/Warehouse Operations
Phones, office reception, written correspondence, accounts payable, payroll, payroll
taxes and banking for five company owned stores. Purchasing, receiving and
inventory control for small warehouse distribution center. Sales orders, invoicing,
order pulling and sales transactions.


Electronic MDRs and Global Adverse Event Reporting

Bethesda, MD – 2007

Developing & Managing Complaint Procedures for Medical Devices

The Center for Professional Development
San Francisco, CA – 2003

How to Develop and Administer a Budget

Skillpath Seminars
Tampa, FL -- 1998

Team Building, Mentoring and Coaching Skills for Managers and

Fred Pryor Seminars
Tampa, FL – 1997

How to Deliver Exceptional Customer Service

Fred Pryor Seminars
Tampa, FL -- 1996

Microsoft Word, Works, Excel, Publisher, Outlook, Trackwise, SAP, Great Plains
Dynamics, Macola Progression, Aldus Pagemaker, JD Edwards, Lotus Notes, Siebel
eMedical version 7, Field Force, ReCast-Manman, LCSS, FedEx Unishipper, UPS