OBJECTIVE

Obtain a full time permanent position in Quality Assurance, Service Management,

Training & Development, Occupational Safety, Marketing or Project Management uti
lizing my education and experience.
EDUCATION
M.S.-Cross Disciplinary Professional Studies
Rochester Institute of Technology-Rochester NY
Service Management/Human Resource Development
B.S.-Applied Arts & Sciences
Rochester Institute of Technology-Rochester NY
Quality Management and Disaster & Emergency Management
Certificates: Disaster & Emergency Management, Basic Quality and Quality Impleme
ntation.
A.S.-Liberal Arts & Sciences
Monroe Community College-Rochester NY
SALARY REQUIREMENT
90-170K
RELOCATION
No
TRAINING
510(k) & PMA-AvaMed, 2007
Internal Auditing to ISO 9000-R.I.T. Center for Quality and Applied Statistics
ISO 9000 Documentation- R.I.T. Center for Quality and Applied Statistics
CPR & AED Training, Henrietta Ambulance August 17, 2009
CERT (Community Emergency Response Team)-MCC Homeland Security Training Institut
e, 2004
Fire Safety/Extinguisher Training, Monroe Extinguisher 2009
ESD Awareness, 2009

AFFILIATIONS
Golden Key International Honor Society-Inducted 2004

COMPUTER EXPERIENCE
Microsoft Office-Excel, Word, PowerPoint
QCBD-Quality Collaboration By Design-Quality Management Database w/electronic si
gnatures.
Access 97-Maintained document control database & report generation, complaint da
tabase
Snagit 7
SBT Inventory System-Monitored inventory system, sales order and pick list gener
ation
EMPLOYMENT HISTORY
Quality Assurance Coordinator, Confidential (Electronics Manufacturer), Rocheste
r NY 8/08-Present
Responsibilities: ISO Implementation & preparation for certification. Developme
nt & Execution of ISO9001 Implementation Plan: Developed ISO9001 Implementation
plan, training program, and conducted ISO9001 Implementation Training for all em
ployees within the organization. Coordinate and lead ISO Implementation progres
s meetings and completed multiple RFQ's for ISO registrars. Development & Manag
ement of Document Control System: Developed & manage document control system. D
eveloped Document Control training program and provided Document Control trainin
g for all employees. Development & Management of Internal Auditor Program: Dev
eloped Internal Auditor Training program and trained 5 employees to become inter
nal auditors. Lead monthly internal audit team meetings. Developed and maintai
n internal audit schedule and created tools required for conducting internal aud
its. Conducted numerous internal audits (lead auditor and associate auditor) an
d provide support to internal auditors. Development & Management of Corrective
and Preventive Action System: Enhanced Corrective and Preventive action system.
Developed Corrective and Preventive Action Training program and conducted CAPA
training for all employees. Maintain and manage the CAPA database and generate
CAPA trending for management review. Conduct verification and effectiveness che
cks for all CAPA including Internal Audit CAPA. Lead weekly CAPA meetings to fa
cilitate closure of CAPA. Development of Internal Audit Training Program: Devel
oped Internal Audit training program and provided training for all employees to
make them aware of what to expect during internal audits and how the information
obtained will be used for continuous improvement. Misc. Responsibilities: Trend
and analyze CAPA, RMA's, DMR's, test, and inspection data. Work on project tea
ms as assigned. Coordinate RMA review meeting & generate report for team discuss
ion to determine if any RMA require CAPA. Generate RMA CAPA as determined by th
e Manufacturing Quality Manager. Complete supplier surveys as needed.

Quality Engineer-Compliance, SIGMA International, Medina NY 8/07-8/08

Responsibilities: Responsible for compliance to QSR including FDA, CMDR and ISO
in a medical device manufacturing environment. CAPA Management: Responsible for
training, overseeing Corrective and Preventative Actions implementation, CAPA da
tabase management (QCBD) and leading weekly CAPA meetings. Internal Auditing: Cr
eate & manage auditing schedule, internal auditor training, perform internal aud
its of various departments & processes to insure compliance with regulatory requ
irements. Field Corrections/Recalls: Monthly updates to FDA, management of corr
ection/recall data including the collection and maintenance verification for cor
rections performed. Other Responsibilities: Baseline reporting, regulatory
review of work completed by Jr. Compliance Engineer, assist with new hire interv
iews, ETL quarterly inspections, participate in 3rd party audits, serve as back
up for Quality/Regulatory Affairs Director as needed.
Quality Analyst, Getinge USA, Rochester NY 5/03-8/07
Responsibilities: Complaint Management: Review and report written, electronic an
d oral communications alleging deficiencies related to a medical device or proce
ss. Manage product complaint database in compliance with regulatory requirement
s to ensure integrity of data. Monitor data and analyze complaints for trends r
elated to product or process inefficiency or failure. Lead bi-weekly complaint
status meetings with multiple factories. Internal Auditing: Perform internal/ex
ternal auditing of various departments & facilities to insure compliance with re
gulatory requirements. Medical Device Reporting: Investigate, document and subm
it Medical Device Reports to the FDA for injury or product malfunction claims.
Field Corrections: Manage field correction activity information from factories a
nd facilitate report of correction to field service personnel. Collect and main
tain verification of corrections performed. Generate FDA rational documents for
corrections not reported to the FDA. Document Control Management: Assist in th
e development and maintenance of standard operating procedures in effort to meet
ISO compliance requirements. Major Accomplishments: Assisted in development of
medical device product/process complaint system in pursuit of compliance with r
egulatory guidelines. Assisted cross functional team in the development and mai
ntenance of defect reporting system and ISO9001: 2000/ 13485 registration prepar
ation.
Document/Data Control Supervisor, STS duoTEK, Rush NY 5/01-9/02
Responsibilities: Document & Data Control duties included: review and sign off o
f standard operating procedures, participate in FDA/ regulatory audits, maintain
electronic and hardcopy standard operating procedures in compliance with FDA an
d ISO regulations, maintain Access database of information regarding standard op
erating procedures, forms, regulatory documents and confidential client informat
ion to ensure ISO and FDA compliance. Other duties performed: QA Technician duti
es-auditing in progress testing to ensure GLP compliance and review/release of G
LP and GMP reports. Major Accomplishments: Developed document control training p
rogram for employees in a laboratory environment, solely managed/controlled qual
ity documentation in compliance with regulatory agencies and reorganized entire
corporate archive facility.
Account Manager, Vertis Media & Marketing (IMPCO), Rochester NY 7/99-1/01
Responsibilities: Manage customer pharmaceutical accounts with responsibilities
in the following areas: quality assurance, client audits/FDA guidelines, direct
marketing project development, project implementation, sample fulfillment, produ
ct packaging, problem resolution and report analysis. Major accomplishments: Ch
ampioned internal process improvements resulting in an increase in customer sati
sfaction for pharmaceutical accounts. Production Transition Team Success-Aggres
sively worked on the transition of client production/fulfillment functions from
a vendor to an in-house operation.
Program Manager, IMPCO, Rochester NY 5/98-7/99
Responsibilities included: Coordinating pharmaceutical direct marketing projects
with internal departments in a production environment i.e. IT, Print Services,
Fulfillment, Lead Processing, Data Entry and Finance, Provide leadership, traini
ng and coaching to account team, secondary contact for customer account, billing
, ISO 9000 procedure documentation and audits (internal & external), problem res
olution, reporting, inventory/fulfillment management and response management.
Customer Service Coordinator, IMPCO, Rochester NY 10/96-5/98
Responsibilities included: Pharmaceutical response management for sample fulfill
ment, data processing, problem resolution (corrective & preventive), and creatio
n/maintenance of ISO9000 procedures/forms, order processing and reporting.
Quality Control Specialist, IMPCO, Rochester NY 3/95-10/96
Responsibilities included: Supporting Quality Control Supervisor, employee train
ing & evaluation, problem resolution, create/maintain ISO 9000 procedures, repor
ting and administrative duties as required.
Inbound Call Center Supervisor, IMPCO, Rochester NY 3/94-3/95
Responsibilities included: Supervising 20 employees, conducting new hire intervi
ews and employee training/coaching.
Inbound Call Center Representative, IMPCO, Rochester NY 10/92-3/94
Responsibilities included: customer service for business-to-business and busines
s to end user products and services.

REFERENCES
Furnished upon request