Karen M. Anderson

*** ******* **. *. 651-***-****

Maplewood, MN 55119 acsu9b@r.postjobfree.com

Professional Experience

MR Instruments March 2012-PresentOctober 2015

Privately held Medical Device Company manufacturing MRI Coils

Quality Assurance/Document Control Minnetonka, MN

Certified Auditor for ISO 13485

Assisted in FDA 510(k) submittal of a class II Medical device

Assisted in the 60601-1 submission for testing to bring class IIB product to market

Wrote and compiled Technical File as required by the European Union Medical Device

Directive, for Class IIB Medical Device. The device received CE Mark certification after

the Technical File was audited

Liaison to FDA, HealthCanada, JPAL, BSI and Emergo for MR Instruments

Planned and executed internal audits to ISO 13485, which included auditing all areas

These audits also met the requirements of FDA quality system regulations.

Planned, wrote and conducted annual quality system management review meeting

Planned and implemented compliance to new or revised quality standards

Conducted vendor evaluations and maintained vendor matrix

Trained personnel to company and quality procedures

Maintained the logging and handling of complaints, nonconformances, deviations and

provided corrective and preventative action reports for investigations

Responsible for all Quality Assurance strategic goals and activities

Liaison to key customers corroborating on all quality issues

Work directly with Change Owners to execute Change Request

Northwestern Fruit Company 2006- 2012

Privately held produce distributor

Finance St Paul, MN

Achieved an enhanced receivable ratio which increased by 6% with the implementation of

recommended restructuring in key areas identified. Improved productivity and business

performance with successful implementation of streamlined processes including task

reassignment. Responsible for the collection of 82% of overdue accounts, with the

implementation of aggressive collection efforts, and revised payment programs for accounts in

default.

Karen & Associates 1995-2006

Business Owner; firm representing giftware St. Paul, MN

Successfully managed the operations of the company through effective implementation of

business plan. Achieved sales growth with the conduct of exceptional events and shows and

excellent customer service in providing program planner support/training to customers

including market planning techniques and product placement.

Karen M. Anderson

931 Glendon St. N. 651-***-****

Maplewood, MN 55119 acsu9b@r.postjobfree.com

Hearing Components 2002- 2005

Privately held 3-M spin off company manufacturing foam products

National Sales Manager Oakdale, MN

Provided sales leadership and achieved a sales performance of $1.2 million through

aggressive sales efforts in marketing foam products of hearing devices to manufacturers,

distributors and audiologists. Developed and implemented educational marketing programs

successfully and conducted exceptional technical training and product familiarity for

audiologists in both accredited and non accredited courses.

Education

Augsburg College, Minneapolis, MN

Graduated 1995

Bachelors of Arts, International Business, Business Administration, Minor Economics

Relevant class work

ISO 13485: The new revision 2015

Quality Practices CMAE 1522 2014

Manufacturing Processes and Production CMAE 1518 2014

EN-60601 and how to maintain MDD Compliance 2014

CMDCAS for Medical Device Manufactures 2013

Corrective and Preventative Actions 2013

Moving from Internal Audit to Internal Control 2013

Post Market Surveillance: Vigilance and PMCF 2013

Essentials of ISO 14385:2003 2012

Internal Auditing Training for ISO 13485 2012

Intro to CE Marking for Medical Devices 2012

How to Maximize benefits of ISO certification 2012

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