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Project Manager Quality

Location:
Charlotte, NC
Posted:
October 15, 2013

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Resume:

JAMES A. BAKER

**** ****** ****, **** ****, SC **730

803-***-**** Hm Off • 803-***-**** Cell

*************@***.***

S ummary

Quality Manager with eighteen years of increasing responsibility and experience in the areas

medical device manufacturer quality, compliance and field service operations. Manage

corrective action – preventive action (CAPA) system. Project manager, lead CAPA and other

business level projects. Senior Operations Manager leading direct reports, cross-functional

teams, and heavily matrixed teams in support of Biomedical Engineering field service, depot

service, and back office operations. Advanced computer skills; business quality representative to

software validation and verification, website and portal administrator. Expert in quality tools and

compliance systems. Develop quality management system (QMS), policies and procedures.

Lead auditor, prepare corporation and host external audits from the FDA, ISO accreditation,

Joint Commission and a host of others. Experienced Lean leader and instructor, Six Sigma

greenbelt certified, and TQM Coach. Organize, lead, and teach 5S events.

Employment History

General Electric Healthcare – Diagnostic and Clinical Services

Quality Manager 09/1997 – 06/2013

Business representative to external inspection agencies at corporate and customer

locations (ISO 9001 / ISO 13485, FDA, CMS, Joint Commission, DNV, State

inspections, etc.). Recognized subject matter expert (SME) for regulatory and

accreditation standards and related issues. Represented the business during an

unannounced FDA audit, resulting in only minor recommendations.

Developed and implemented a nationwide internal auditing program compliant with

21CFR820 standards and ISO 9001 – ISO 13485 requirements. Lead Auditor performing

internal audits in all business segments including operations, support, finance, back office

and management. Perform external audits at contracted locations; consult on corrections

to compliance issues. Train new auditors and set audit schedules. Due to Quality Team

audits and team training of operations staff, national field service program received zero

findings during recent ISO certification inspections at multiple locations nationally.

Lead Corrective Action – Preventive Action (CAPA) review board. Analyze business

metrics, audit results (nonconformities), medical device reports (MDRs), product

compliant reports, Voice Of the Customer (VOC), identified trends, or other opportunities

for entry into the CAPA system. Provide oversight and guidance for CAPA projects

ensuring outcomes are appropriate, compliant and timely. Control documentation of

project outcomes for regulatory/accreditation agency inspection.

Lead and manage projects (General business, CAPA, Product Development, Product

Quality, IT) utilizing cross-functional, geographically separated, matrix based teams. Led

project creating national call center for all field service entities. Project member -

developed networking system and uptime monitoring product for multi-vendor patient

monitoring networks. Led project validating wireless mobile tablet platform for field

service documentation and database operations.

Lean Leader/Instructor, Six Sigma – Green Belt certified, Total Quality Management

(TQM) Coach: Lead and teach 5S events. Author Lean modules to teach Lean principles

and address specific business needs. Design, lead and teach TQM learning events and

facilitate workout sessions.

Develop and author business level Quality Management System (QMS) policies and

procedures, train and implement QMS cross-functionally and cross business segments.

Coordinate the development of business metrics, metrics websites, and lead Management

Review to support QMS effectiveness. Maintain documentation control of QMS relevant

documents, and revision management process.

Computer Software Validation (CSV), business quality representative. Use technical

writing skills to author user / service manuals, testing protocols and other technical

documents. Approve all validation activities including all documentation, testing,

verification/validation, and risk management.

Quality & Compliance Specialist

Lead Auditor, Regulatory and Accreditation Standards (SME), Computer and automation

(SME), website and portal administrator, develop audit program.

AMSCO/STERIS Corporation

Region Manager 11/1996 - 09/1997

Managed all aspects of operations for the Biomedical Engineering in-house and field

service programs in the Virginias and Carolinas region.

Manage 21 direct reports and various matrixed reports including Biomedical field

engineers, X-ray, laser, anesthesia, respiratory, and other specialists. Responsible for

personnel hiring, annual reviews, salaries, work assignments, and training.

Directly involved with contract sales and contract Ts & Cs. Doubled top line first year –

number two in growth with a healthy contribution margin. Company profitability led to

purchase by GE. Instrumental in developing, deploying, and implementing the Say Yes

program. Contracted $128,000 in systems not previously handled by the corporation.

Customer interface for all quality and compliance issues. Represented the company

during all external inspections at contracted customer locations. Provided intervention

when findings occur. Resolved issues surrounding Joint Commission findings

threatening the medical center’s ability to provide healthcare.

Manage contracted service for medical devices by third party providers. Ensured

contractor quality and compliance. Sourced vendors and coordinated vendor

qualification with corporate sourcing team.

US Air Force, Keesler AFB – Southeast Medical Equipment Repair Center (MERC)

Director, Biomedical Engineering 01/1994 - 06/1996

Manage all aspects of the Biomedical Engineering program for the Air Force second

largest medical center and directed operations for mobile field service teams providing

service to advanced biomedical equipment at military locations throughout the

southeastern United States and associated off shore facilities. Direct a team of thirty-two

Biomedical Engineering technicians, specialists, and working managers.

Medical center operations management include but are not limited to budgeting,

contracts, supplies, vendor quality, training, organization structure, work assignments,

mission strategy, executive representative to Air Force headquarters operations, and

community representative for emergency resources. Member of multiple committees,

including the Executive Committee, Safety Committee, Equipment Authorization Board,

Environment of Care Committee, Emergency Preparedness Committee and others.

Project Manager coordinating local and Air Force level projects, including strategic

business development, government contracts, capital equipment purchases, small

construction and renovation.

Build computer systems and network operations for Biomedical Engineering, including

scanning capability and a Level V Raid assembly, which recovered 96 square feet of

filing cabinet footprint.

US Air Force, Little Rissington AFB, United Kingdom

Supervisor, Biomedical Engineering 06/1991 - 01/1994

Supervised team of 14 Biomedical Engineering technicians servicing the Air Force

largest contingency hospital. Designed training materials and trained technicians to

service specialty equipment.

Managed repair parts and supplies for medical devices supporting 1500 beds.

Designed X-ray room installation (13 rooms), including transformers and

primary/secondary wiring requirements, room construction elements to meet system and

“in country” power and physical demands.

Supervised maintenance and servicing of multiple Deployable Medical Systems

(DEPMEDS) and other contingency assets in the European and Gulf War theaters.

Authored technical training program materials for supported medical equipment and

systems. Supplied materials Air Force wide to contingency commands supporting like

assets. Materials eliminated waste, reduced risk, and created standard work.

At the direction of Central Command (CENTCOM), performed Gulf War theater

evaluation of biomedical asset readiness and support for all services. Resulted in major

overhaul and replacement of readiness assets.

US Air Force – Various Positions

Plant/Facility Manager, Safety Officer, Supervisor, Technician 12/1982 - 06/1991

Education and Training

University/College Degree Major

American InterContinental University MBA Healthcare Management Focus

Limestone College Bachelors of Science Computer Sciences

Other Training / Certifications

Certified by the International Certification Commission and the United States

Certification Commission for Clinical Engineering and Biomedical Technology, ID#330275

Certified Total Quality Management coach, and instructor – US Air Force certification

program

Six Sigma Green Belt Certified – (GE Healthcare Institute)

Total Quality Management coach, US Air Force program

ISO 9001 and 13485 trained (G.E. Healthcare)

Advanced X-Ray systems and X-Ray installation (Air Force)

Biomedical Equipment Technician – Basic Course (Air Force)

Noncommissioned Officer Leadership School (Air Force)

Noncommissioned Officer Academy (Air Force) – Distinguished Graduate



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