Quality Assurance Medical Device

James A. Cochie

* **** ***** ****, ***** ***, Winston-Salem, North Carolina, 27101

Home Phone 336-***-**** ( E-mail abnoux@r.postjobfree.com

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OBJECTIVE

Seeking a leadership position in an FDA regulated

manufacturing industry with a focus in Quality Assurance,

Regulatory Affairs and/or ISO 9000/13485 disciplines

QUALIFICATIONS

> In-depth knowledge of ISO 9001 & ISO 13485 Standards

criteria, FDA regulations, European Medical Device

directives and general quality principles. These

qualifications have been realized in facilitating ISO

project teams, advising organizations on FDA regulatory

interpretations and continued improvements through the

application of quality principles.

> Excellent technical writing skills have proven to be an

invaluable tool through the creation of validation

protocols/reports, quality system documentation including

the writing of the company Quality Manuals and the

submissions of FDA premarket notifications.

> Proven leadership skills in a systems approach to managing

projects utilizing the involvement of all company

personnel.

WORK HISTORY

2004-Current Ventlab Corporation, Mocksville, North Carolina

Medical Device Manufacturer

Leads, develops, implements and maintains all quality assurance

and regulatory programs to ensure compliance with Food and

Drug Administration regulations, Heath Canada regulations and

the European Union's Medical Device Directives.

Accomplishments

2004-2005 - Led the management team in a successful

implementation project of obtaining ISO 13485 certification

and CE marks for many Ventlab products. This certification

opened market opportunities in Europe and Canada.

2005-2009 - Instrumental in the application of quality

systems in two of the company's Chinese facilities. Worked

closely with the Chinese to attain ISO certification and FDA

compliance

Led efforts with company's China manufacturing component to

obtain certification to ISO 13485 for the facility in Zhuhai,

China

Served as Director of Regulatory Affairs and Quality

Assurance from 2004 - 2009 and currently holds the position

of Vice-president of Regulatory Affairs and Quality

Assurance.

1981-2004 Monaghan Medical Corporation, Plattsburgh, New York

Medical Device Manufacturer

Quality Assurance/Regulatory Affairs Manager (1984 - 2004)

> Developed, implemented and maintained all quality assurance

and regulatory programs to ensure compliance with Food and

Drug Administration regulations, Heath Canada regulations

and the European Union's Medical Device Directives.

> Designed and developed company training programs.

Accomplishments

2002-2003 - Successfully coached and facilitated a cross-

functional ISO project team that completed ISO 13485

registration upgrade in six months. This registration

continues to allow for the sale of product lines to Canada

and Europe.

1985-2004 - Company liaison for 13 bi-annual

inspections/investigations. No significant regulatory actions

(one "Regulatory Letter" and one "Warning Letter").

Coordinated to completion, four product recalls in twenty

years, all class II voluntary actions. And, authored and

coordinated the successful submittals of twenty-two 510(k)

premarket applications with the FDA.

1985-1987 - Redesigned a fluidic ventilator for use in

Magnetic Resonance Imaging (MRI) creating a niche market

opportunity for continued growth of a mature product equaling

in excess of 100 additional ventilators and totaling

additional gross sales revenues of over $700,000.

1997 - Led a cross-functional ISO project team and completed

ISO 9001 registration in twelve months. This included the

application for and awarding of a CE Mark for the company's

Peak Flow Meter product.

1997 - Implemented programs that researched and applied bar

codes to Monaghan products.

Service Department Coordinator/Technician (1981 - 1984)

> Scheduled work assignments and acted as customer liaison

for service related affairs, including field service calls

around the country.

> Repaired, maintained and calibrated the Monaghan product

line, including both electronic and fluidic products.

Accomplishments

1984 - Designed and conducted in-depth training seminars on

the 225/SIMV Ventilator for hospital bio-medical technicians,

dealer and independent service organizations. This program

led to continued success in product use entering the mature

stage of its life cycle.

1975-1979 Integrated Avionics Component Specialist, 380th Bombardment

Wing, Plattsburgh AFB, US Air Force

> Identified malfunctions of avionic equipment to determine

operational readiness.

> Isolated and repaired malfunctions of subsystems, to

include radar systems, communication systems and mission &

traffic control systems.

EDUCATION

2001-2003 SUNY Empire State College

Bachelor of Science degree in Business, Management and

Economics with a concentration in Business Administration

1975-1976 Lowry Technical Training Center, Lowry Air Force Base, Colorado

Technical training curriculum, Integrated Avionics Component

Specialist

COMMUNITY INVOLVEMENT

Past President and Trustee of the Battle of Plattsburgh Association - Not-

for-profit museum corporation

Davie County Chamber of Commerce Executive Board - 2012 Past Chairman

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