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
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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
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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
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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
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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
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(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
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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.
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Computer Software Validation (CSV), business quality representative. Use technical
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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
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service programs in the Virginias and Carolinas region.
Manage 21 direct reports and various matrixed reports including Biomedical field
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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 –
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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
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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
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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
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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,
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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
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business development, government contracts, capital equipment purchases, small
construction and renovation.
Build computer systems and network operations for Biomedical Engineering, including
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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
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largest contingency hospital. Designed training materials and trained technicians to
service specialty equipment.
Managed repair parts and supplies for medical devices supporting 1500 beds.
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Designed X-ray room installation (13 rooms), including transformers and
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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
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(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
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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
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Certification Commission for Clinical Engineering and Biomedical Technology, ID#330275
Certified Total Quality Management coach, and instructor – US Air Force certification
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program
Six Sigma Green Belt Certified – (GE Healthcare Institute)
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Total Quality Management coach, US Air Force program
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ISO 9001 and 13485 trained (G.E. Healthcare)
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Advanced X-Ray systems and X-Ray installation (Air Force)
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Biomedical Equipment Technician – Basic Course (Air Force)
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Noncommissioned Officer Leadership School (Air Force)
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Noncommissioned Officer Academy (Air Force) – Distinguished Graduate
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