Karen Wend

**** ******* *** *, #***, Sarasota, FL 34233

941-***-****

ablz4q@r.postjobfree.com

* *********: Organizational Project Management

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* ********** *******

Regulatory Management

Mi-Way, Inc.

03-02 to 05-04

. Consultant for the development of ISO/GMP procedures and

researching the availability of OEM manufacturing for new

contact lens material and lenses.

Benz Research and Development Corp.

04/89 to 03/02

. Initiated and wrote major portion of documentation for

quality system (SOP, STM, CAL, CAPA, Design and Training)

and project manager for ISO certification.

. Expedited projects with short lead times, demonstrated

strong leadership, and motivational skills, which led to

greater responsibilities.

. Prepared documentation and arranged testing, Reviewed

clinical studies with outside service for three new Medical

Device product applications for FDA submission, all were

approved.

. Responsible as Project Manager for successful

implementation and execution of plan to obtain all

regulatory approvals to market a Class II Medical Device in

a 7-month period and completed. This involved writing

procedures, developing testing and labels, training,

regulatory inspections with implementation of ISO9001,

EN46001, FDA equivalency and CE Mark. Additional task

included travel to UK to coordinate with OEM, set up office

to handle QA, shipping and receiving and resolve any issues

that would arise from an overseas office.

. Presented Regulatory training for 40+ employees and

completed internal auditing.

. Acted as company liaison for all regulatory audits in the

UK and US.

. Administered CAPA and customer complaints, investigation

and resolution, working closely with both engineering and

manufacturing.

QA/QC Management

Benz Research and Development Corp.

04/89 to 03/02

. QA/QC Manager for 7+ years, responsible for hiring, firing,

training and annual reviews with goal setting and salary

recommendations for eight employees.

. Generated computer integrated production scheduling and OEM

purchasing to meet customer needs.

. Assisted with production, product development and

development of new testing, including continuous process

improvement.

. Managed and preformed product inspection, testing,

calibrations and maintenance of records.

. Responsible for vendor contact coordination and purchase

orders.

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4 Customer Relations Manager/Organizational Development

Equity Exchange Services, Inc.

David D. Bone, P.A.

04/04 to 06/10

. Vice President responsible for initiating in-house sales,

contractual preparation and funding for 1031 Starker

exchange transactions, handling at intervals over 25

million in funds.

. Personally completed over 200 new exchange transactions in

2005.

. Starting in 2006, annually administered 80+ real estate

closing transactions with property values up to five

million dollars per transaction.

. Coordinated with developer for a new website: prepared

script, pictures and updated news articles as needed.

Regal Springs Trading Co.

09/02 to 05/03

. Gathered and prepared logistical reporting for domestic

product sales of International Farmed Commodity (Tilapia).

. Prepared PowerPoint demonstrations for sales presentations

Benz Research and Development Corp.

04/89 to 03/02

. Personally managed a global territory worth over five

million in sales annually.

. Responsible for initiating, developing and maintaining 200+

accounts, negotiating sales contracts and compliance.

. Utilized QA expertise, technical troubleshooting and

problem solving skills to facilitate sales success in a

declining marketplace and increased sales in 2001 for three

active product lines, 14%, 16% and 41%, respectively.

. Interfaced with five departments utilizing strong

organizational skills to complete production forecasting

schedules to meet sales needs and growth for four major

product lines. In addition, completed ongoing coordination

with OEM vendor using this forecasting plan to schedule

their production changeover to our disposable contact lens

product line which consisted of 18 sizes valued at over two

million dollars annually.

. Organized and participated in corporate sales/training

presentations including materials, testing, machining

specifications and in-house demonstrations. This included

both domestic and international sales expositions, which

took place in US, UK, Europe and Asia.

. Integral member of the design team for all new products.

Responsible to offer suggestions and feasibility

evaluations for new products based on interactions with

customers, including surveys, newsletters and direct

interaction.

. Initiated and coordinated development including safety

testing, inspection and packaging in collaboration with

outside partner for marketing a new dry polished

Intraocular lens internationally.

Shipping and Receiving / Accounting

Equity Exchange Services, Inc.

04/04 to 06/10

. Responsible for bank reconciliation for Exchange and Trust

bank accounts.

. Signor for Exchange accounts where funds are deposited and

transferred to end purchase or client. Responsible for as

many as 30 accounts open at a time with a value up to 25

million dollars.

Benz Research and Development Corp.

04/89 to 03/02

. Shipping Manager for 7+ years, responsible for hiring,

firing, training and annual review with goal setting and

salary recommendations for five employees (1

international).

. Responsible for all shipping operations plant wide

processing over 150 shipments monthly worth over five

million dollars in sales annually.

. Organized Inventory control tracking with barcodes for

automatic conversion to accounting system (MAS90) for

shipping paperwork and freight vendors.

1 Previous experience

Prior to 1984

. Several jobs from banking to Industry as full charge

Bookkeeper.

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5 Education

. A.A.S. Medical Laboratory Technician 1984 - Board

Certified 1984

. B.A. Eckerd College - Organizational Development -

Corporate 2005

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