James W. Burger, Jr.

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

Eastlake, Ohio 44095

440-***-**** (Home)

440-***-**** (Cell)

E-mail: ab9qfa@r.postjobfree.com

Executive Summary

Accomplished business professional with extensive experience in Quality and

Regulatory for Medical Devices, Engineering and Design. Possess proficient

skills in the following areas:

Effective utilization of technical and analytical skills

Strong project management skills

Advanced working knowledge of process validation protocols

Excellent knowledge of FDA regulations and requirements for medical devices

and pharmaceuticals( QSR & ISO 13485)

Problem-solving and decision-making in all areas of Engineering

Six Sigma Green Belt Training

ISO 9000 and FDA auditor

Reliability Engineer

Strong communication skills, both oral and written

Ability to interface well with all levels of the organization

Team-oriented with excellent interpersonal skills

Advanced computer skills including Microsoft Office, PowerPoint, Excel, MS

Project, Statgraphics, and Mini-Tab

Flexible, reliable, self-starter who uses independent judgment and

initiative

Professional Experience

The Hygenic Corporation

10/11 to Present

Director, Quality Systems

Responsible for directing the organizations Quality System (QA/QC)

activities insuring that all products/services exceed the corporate and/or

customer's requirements in addition to the requirements of the regulating

bodies (FDA, ISO, MDD). Manage both the HCA Process and Sourcing

Validation Teams while generating the Validation documentation for HCM

projects. Manages the Corrective Action/Preventative Action (CAPA) system

for both internal and external requests. Manage the Non-Conforming

Material Review (NCMR) system for both internal and external issues.

Performs internal/external audits. Facilities weekly Quality meetings with

our two major suppliers of OTC products and the HCM Quality Manager.

Provides compliance support to NPD and Marketing teams on new and

continuous improvement projects. Manage one direct report (CAPA/Complaint

Manager) and 3 indirect reports (QA Inspectors).

Advanced Platform Technology (APT) Center of Excellence, Louis Stokes

Cleveland Veteran's Affairs Medical Center

05/05 - 09/11

Quality Systems Manager

Serve as only Quality Systems Manager of Center supporting rehabilitation

research by adapting cross-cutting foundational technical platforms to meet

specific needs for advanced prosthetic systems, sensory aids, and other

clinical applications.

In charge of establishing a Quality System meeting the requirements of the

FDA at a research/academic organization. Prepare numerous Standard

Operating Procedures (SOPs), a Quality Plan and other Quality procedures.

Conduct training on SOPs. Prepare, review and submit IDE submissions and

IDE addendums. Prepare and submit Annual Reports and Current Investigator's

listing for approved IDEs. Prepare, review and submit IRB protocols and

informed consent forms. Prepare Design Control documents as templates for

principal investigators and other engineering staff. Make presentations to

various levels of the organization on Quality System requirements and

Quality System documentation. Establish a Supplier Quality program to

include SOPs, forms and a supplier survey to determine the need for audits.

Conduct annual supplier audits on the 3 major suppliers and qualify 5

others through the survey analysis. Serve as point man for the external

sterilization of all the devices used by our clinical investigators,

provide the same service to Cleveland FES Center investigators and an

external startup company licensing our technology. Work with the sterilizer

to obtain a validated sterilization cycle. Represented the Center at local

and national conferences. Mentor new and junior staff.

Icon Interventional Systems, Inc.

02/04 - 05/05

Manufacturing Engineer

In charge of manufacturing and operations for a small start-up medical

device company. Prepared Design Control documentation including master

design and development plans Design Output Matrix, establishing Quality

Systems procedures, established the Quality system, audited vendors, set up

a cleanroom manufacturing area including the certification of the cleanroom

and the manufacturing equipment, and providing design assistance to the R&D

Director and Chief Technical Officer.

Oakwood Laboratories, L.L.C.

07/03 - 12/03

Validation Engineer (Contract Assignment)

Prepared validation protocols for a small parential pharmaceutical

manufacturing company. Assisted facility engineer in the installation of

new equipment and the construction of the facility.

STERIS Corporation

03/01 - 03/03

SR. Validation Engineer/Facilities Engineering Manager, 01/02 - 03/03

Managed a staff of seven engineers covering the manufacture of STERIS

SYSTEM 1, the chemical packaging of STERIS 20 (the sterilant utilized in

the SYSTEM 1), and new product process development.

. Authored, approved and executed validation protocols for the equipment

utilized throughout the facility.

. Managed facility issues including control of the HVAC system, hazardous

waste collection and disposal, EPA monitoring and reporting activities,

and OSHA activities.

. DOT certified for Hazardous Waste management.

. Certified Internal Auditor for ISO.

. Expert in 21 CFR 820 (QSR) 21 CFR Part 11, 21 CFR 210-211 (cGMP), ISO

9000, and ISO 13485.

Process Validation Engineer, 03/01 - 01/02

. Authored, approved and executed validation protocols for over 40 pieces

of equipment, packaging lines and test equipment utilized throughout the

facility.

. Revised existing procedures to fall within guidelines of the GHTF

Guidance document for process validation from the FDA.

. Trained various personnel throughout the facility on validation

requirements, methods and procedures.

Norman Noble, Inc.

06/98 - 03/01

Validation/Process Engineering Manager, Laser Micromachining Division

Managed validation activities required to comply with current FDA QSR

regulations and Norman Noble's customer requirements.

. Authored, approved, and facilitated validation protocols required to

completely validate the manufacturing processes.

. Conducted DOEs, duration studies, and controlled Engineering experiments

to establish maximum allowable process window.

. Engineering Liaison with customer's New Product Development, Quality

Assurance, Supplier Quality, and the Pilot Manufacturing groups.

. Project Manager for all Cordis new stent projects.

. Analyzed and investigated problems to determine the root causes and

proposed solutions.

. Qualified Internal Auditor to ISO 9000.

C.R. Bard, Inc., Bard Interventional Products Division

10/90 - 05/98

Projects Manager, 01/97 - 05/98

Managed and led the internal efforts of introducing State of the Art

technology into the Interventional products Division via Vertical

Integration of manufacturing and assembly processes to improve quality,

reduce inventory requirements, improve the assembly process, reduce

manufacturing cycle times, and reduce costs.

. Project team leader on numerous cross-functional teams. In this

capacity, established a Manufacturing Cell which included researching

available equipment, justification for the capital expenditure,

installation of all equipment, and fine-tuning the process to create

components to drawing specifications.

. Participated in the Divisional Strategic Planning activities responsible

for generating and maintaining monthly tracking of department budget,

project budgets, and capital expenditures.

. CAD/CAM experience: Solid Works

Advanced Manufacturing Engineering Supervisor, 11/94 - 12/96

Supervised activity of three Process Engineers and two Engineering Techs in

the Vertical Integration of manufacturing processes.

. Improved quality and assembly process, reduced inventory requirements,

and reduced manufacturing cycle times and costs.

. Participated on numerous new product, line extension, process

enhancement, and cost reduction cross-functional project teams as either

a team member and/or team leader.

. Responsible for coordination and start-up manufacturing on all new and/or

redesigned products.

. Generated and maintained monthly tracking of department budget and

capital expenditures.

Process Engineering Supervisor, 04/92 - 11/94

Supervised activity of five Process Engineers, two Engineering Techs and

Document Control staff in the support of all manufacturing and processes at

the Mentor, Ohio facilities.

. Coordinated the transfer of several product lines to the Bard facility in

Puerto Rico.

. Participated on numerous cross-functional project teams as either a team

member and/or team leader.

Sr. Process Engineer, 10/90 - 03/92

Responsible for the engineering support of all manufacturing and processes

at the Mentor, Ohio facilities.

. Directed the activities of the Document Control clerk, Maintenance

personnel, and Service personnel.

. Participated in the review of all customer complaints and provided

Engineering input.

. Provided daily service support to customers.

. Coordinated all on-loads of new products and/or line extensions with

Boston facility.

Argo-Tech 11/88 -

10/90

Sr. Production Process Engineer, Navy Power Division

. Processed components to optimize manufacturing with available equipment

. Prepared operation sketches and routings.

. Reviewed deviated components to evaluate most effective method of repair.

. Consulted with both Quality Control and Product Engineering.

. Attained DOD and DOE Top Secret Security Clearances.

. CAD/CAM experience: Catia.

Kennametal Inc. 10/80 -

11/88

Sr. Systems Engineer, Systems Engineering, 04/83 - 11/88

. Analyzed customer's work pieces to recommend most efficient method of

manufacture to obtain specification requirements.

. Prepared concept drawings; supervised Engineering personnel in the

preparation of quote and final manufacturing drawings.

. Assisted sales personnel in quote presentation and order installation/run-

off. Extensive customer contacts.

. CAD/CAM experience: McAuto.

Project Engineer, Production Engineering, 10/80 - 4/83

White Motor Corporation

11/71 - 09/80

Reliability Engineer - Truck Group, 05/79 - 09/80

Sr. Advanced Designer/Group Leader, Custom Engineering - Truck Group, 02/75

- 04/79

Sr. Designer, Production Engineering Engine Group - Truck Group, 07/73 -

01/75

Designer, Custom Engineering - White Trucks Division, 11/71 - 05/73

Fasson Machine Products Division

09/70 - 11/71

Design Draftsman

Motch and Merryweather Machinery Co.

06/67 - 08/70

Draftsman, Machine Design Group

Education:

Bachelor of Science in Engineering, Mechanical Engineering

Cleveland State University, Fenn College of Engineering

Professional Affiliations:

Association for the Advancement of Medical Instrumentation (AAMI)

American Society of Quality (ASQ)

Community Activities:

Eastlake Midget Football, Head Coach

Eastlake Midget Football, Assistant Coach

Eastlake Boys Softball, Manager

Eastlake Boys Softball, Commissioner

Eastlake Boys Softball, Tournament Director - Ron

Boggs Memorial Tournament

Other:

Health: excellent

Married, four grown children

Interests: golf, model making, paint ball

Contact this candidate