Medical Device Quality Control

Michael Koczocik

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

Silver Spring, MD 20901

Cell Phone 413-***-****

Email *******.********@*****.***

Objective Position in Regulatory Sciences which utilizes my education and technical skills

while providing opportunities for continued professional growth.

Education Northeastern University Boston, Massachusetts 02115

Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical

Devices.

Conferral date: December 2012

University of Connecticut Storrs, Connecticut 06269

Bachelor of Science in Medical Technology. 2002 – 2006. Dean’s List

Hartford Hospital Hartford, CT 06102. Clinical Laboratory Education Program,

School of Allied Health.

Certification Board of Registry Medical Technologist MT (ASCP) License # 224620

State of California Clinical Laboratory Scientist # MTA41837

Work

Experience U.S. Food and Drug Administration Center for Devices and Radiological Health.

Office of the Center Director. Silver Spring, MD 20993. June 2012 – Present.

Medical Device Fellowship Program. Health Science Project Specialist

• Assisted with the development of national policy for medical device

labeling.

o Utilized the FDA’s high performance computing program, Sematic

Search and Retrieval Framework (SARF) and various databases to

filter premarket notifications for labeling criteria.

o Researched guidance documents, adverse event reports, regulations

& 510(k) submissions analyzing data to write recommendations for

labeling policy within the center and for subsequent regulations.

o Researched guidance documents and regulations for regulatory

definitions that will be used to formulate policy and regulatory

initiatives for product labeling.

• Tester for FDA’s Unique Device Identification (UDI) system for post

market surveillance.

o Provided internal feedback for data entry and search capabilities of

a preliminary version of the (UDI) database.

• Developed a lateral document to a Standard Operating Procedure (SOP)

for CDRH’s Center Tracking System (CTS) for Guidance Document

development.

• Working member of a subgroup for developing sections of a guidance

document for Pre-Market Application (PMA) labeling.

• Participated in various center staff meetings regarding CDRH projects

concerning various issues, such as: regulations, guidance documents,

policy, global harmonization, registration and listing, adverse event

reporting, promotion and advertising, ISO and IEC standards, Cooperative

Research and Development Agreements (CRADAs), and human factors.

• Worked with Regulations Staff on the clearance process for public

meeting notices, guidance documents, and regulations for Federal Register

publication.

o Reviewed Federal Register notices for conformance and

consistency prior to publication

o Drafted sections of federal register notices for Paperwork

Reduction Act (PRA) and Economic Analysis statements.

• Knowledge of the Food Drug and Cosmetic Act and 21 CFR sections

applicable to drugs and devices.

• Attended several FDA & industry meetings on topics such as Metal on

Metal Hip implants, Human factors, Device Interoperability, Human

Factors, Visual Language for Medical Device Labeling, and Quality

Systems.

Riverbend Medical Group Chicopee, MA 01020. May 2009 – April 2012

Medical Technologist – Generalist, General Supervisor

• Performed a variety of laboratory testing in the areas of chemistry,

hematology, coagulation, urinalysis, serology, and microbiology.

• Performed quality control, calibration, and maintenance on laboratory

instrumentation

• Followed protocol for proper testing, result interpretation, and reporting

• Assisted in the implementation of new analyzers that included validation

studies, concurrent quality control, procedure writing, and employee

training.

• Met the Massachusetts Department of Public Health criteria for a General

Supervisory Role.

o Maintained and operated the entire laboratory of six analyzers

independently during the conclusion of normal business hours and

during weekends.

• Assisted in the Preparation for State, and College of American

Pathologists (CAP) inspections by compiling and organizing records,

assisting in internal inspections to eliminate and reduce discrepancies, and

preparing and arranging work stations.

Baystate Medical Center Springfield, MA 01199. February 2007 – May 2009

Medical Technologist – Microbiology/Serology

• Perform bacteriological and serological testing and analyses on patient

specimens

• Perform quality control, calibration, and maintenance on laboratory

instrumentation

• Follow protocol for proper testing, result interpretation, and reporting

• Participated in healthcare industry “lean” workshops and activities to

devise ways of cutting waste and utilizing resources to enhance efficacy

and output while improving productivity.

• Assisted and Participated in preparation for state and College of American

Pathologist (CAP) inspections by participating in group discussions and

generating dialogue with inspectors.

Skills Computer Skills – Microsoft Office products, FDA/CDRH Center Tracking System

(CTS), Image 2000+ document database, Semantic Search and Retrieval

Framework (SARF), Sunquest Laboratory Information System, Meditech

Laboratory Information System

Languages – Proficient in Spoken Polish

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