MICHELE J. JACOBSEN

abilsi@r.postjobfree.com

**** *** ***. ** •Coon Rapids, MN; 55433 •763-***-**** (H)• 763-***-**** (M)

th

QUALITY & REGULATORY OPERATIONS / DOCUMENTS MANAGER

Combining deep knowledge of regulatory compliance and quality systems, with top tier organization and multi tasking

skills to expertly support and exceed organizational and production goals.

Over 15 years experience in the planning and management of documents, quality systems and electronic training

procedures for medical device and service organizations. Consistently effective in streamlining and upgrading processes,

improving presentation and organization, and coordinating cross functional teams for clarity and accuracy in regulations

compliance.

Core Knowledge and Skills:

•Medical Device Requirements •SOP Compliance •Software Training

•Document Change Systems •Cross Functional Collaboration •Training and Development

•Document Management •Quality Management •Regulatory Compliance

•Process Improvement •Publication Submission •File/Research Management

•US and International Labeling •Industry Research and Analysis •Resource Coordination

PROFESSIONAL EXPERIENCE

Closys Corporation

Quality Systems Document Manager, 2005 present

Formatted, reviewed, and cross referenced all medical device documents, including Quality Manual and SOPs. Product

Requirements, Risk, and Clinical documents. Managed Quality System Regulations, and obtained multiple supplier

information and qualification status per FDA, 21CFR, QSR and ISO 13485 requirements. Conducted audits for on site and

off site suppliers, testing facilities, and manufacturing facility, per FDA 820 and ISO 13485. Designed product labels, per

ISO 1041, FDA Part 801 and MDD requirements with input from Regulatory. Provided cross functional documents support

for regulatory, clinical, and engineering teams. Reviewed bio compatibility packaging and managed all document change

orders per FDA and QSR demands.

St. Jude Medical

AFD MT Training Coordinator, 2009 2010

(Contract through Aerotek)

Managed, prioritized and distributed high volume training tasks for over 300 employees in multiple locations. Created

training lists and requirements for processed Change Requests and verified effectiveness. Identified areas of improvement

and provided best case solutions and meeting with department managers to assist in individual customer needs. Produced

check and key documents, and training metrics for the purpose of ensuring overall effectiveness.

• Closed the gap on non training employees by 40% through detail oriented follow up, and direct positive communication

with employees and managers.

• Exceeded new challenge of SOP requiring 70% of employees to participate in on going training through hands on

management of documents and processes, and effective delivery of necessary information.

• Administered training for an additional 22 CRMD employees, following Minnetonka Quality Manual, producing

desired results outside of expected job duties.

• Intuitively determined individual learning styles and adjusted applications appropriately, improving overall

knowledge of job duties and ultimate performance.

MICHELE J. JACOBSEN PAGE 2

Possis Medical, Inc.

Senior CAD Drafter and Labeling Specialist, 1995 2005

Managed all electronic product and vendor files per QSR, identifying areas of deficiency and implementing necessary

process improvements. Designed and modified AutoCAD files, implementing and updating standards per ASME guidelines

and regulations. Trained and monitored all departments in PLM system proficiency. Cross functional organization and

coordination of packaging and labeling between departments.

• Streamlined packaging process, reducing required number of documents from 11 to 3, resulting in significant time

savings through a more efficient process.

• Saved $10K in company funds by identifying label error due to outstanding and precise attention to detail.

• Elected by executive staff as principle member of labeling and packaging team.

• Support the Bar code implementation team.

• Chosen by VP of Engineering as a member of Information Technology Team to recommend and review new potential

software purchases.

PROFESSIONAL DEVELOPMENT

University of Phoenix

Bachelor of Science in Health Administration

• Project Team Leader in 15 of 20 courses

• Graduated with Honors

Anoka Ramsey Community College

Associate in Arts

Anatomy & Physiology, Medical Terminology, Compliance Online FDA QSR, FDA Device Labeling, Medical Alley

seminars,Train the Trainer, 7 Habits of Highly Effective People, High Performance Team Building, Improving

Business Communications, ISO 9000, GDT Blueprint Reading

TECHNOLOGY SKILLS

•Windchill •Microsoft Office Suite •Auto CAD

•MatrixOne PLM •Project •SolidWorks

•Adobe Illustrator PC and MAC •Visio •Inventor

•Adobe Photoshop •Publisher •CAMtastic

•Adobe Acrobat Professional PC and Mac

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