Array
(
    [var] => cut_url
)
<pre>Array ( [var] => cut_url ) </pre> Resume for George Gary C. for Consultant / Professional & Consulting Services in South Bend, Indiana. Search More Resumes for Consultant on Resumark.com #NP8Z9FFNX
 

Search Resumes

Post Jobs
 


Job Seekers:
Post Your Resume


 

Resume for George Gary C. for Consultant / Professional & Consulting Services in South Bend, Indiana




Occupation: Consultant Industry: Professional & Consulting Services
Country: United States City: South Bend
State: Indiana ZIP: 46613



View Complete Resume   Download Resume [
Array
(
    [name] => cut_url
)
PDF]
Share Share


< Back to search results Preview: For the complete resume and contact info please download it.

Array
(
    [var] => content
    [type] => preview
)
Array
(
    [var] => cut_url
)
George G. C.
South Brookfield Street
South Bend, IN
Tel:
Cell:
Email:
Websites:
?bioID=&perID=
OBJECTIVE
To transition more than years of professional experience in a government, consulting, and industry environment,
into a new position utilizing my analytical, communication and creative skills in the areas of domestic and
international medical device consulting, compliance, and regulatory, including contract positions at medical device
companies and/or permanent positions at medical device consulting companies.
BACKGROUND
I am a medical device quality assurance compliance expert. My career has been concentrating on US/EU medical
device auditing, investigating, compliance, and regulatory except for preparing regulatory submissions. Thus, I am
not a quality engineer nor have set up process validations, design projects, nor have written any regulatory
submissions i.e. k’s, PMA’s technical files, etc. However, I have audited and reviewed hundreds of regulatory
submissions, process validations, design studies, et al quality operations including conducting gap analyses/
reconciliations and have given training and guidance to both governmental and industry personnel in these and other
medical device areas for over years. I have also performed various handson operations, such as preparing/
revising written procedures, preparing CFR baseline reports, conducting out of specification investigations,
and monitoring and maintaining complaints, nonconformances and CAPA’s. I am willing to take CONTRACT
medical device quality assurance assignments anywhere worldwide and travel % including internationally.
SUMMARY
A Selfstarter with good written and oral communications skills and over years of professional experience as a
level II certified international medical device investigator in the US government or as a contract consultant and
regulatory compliance auditor in the medical device industry. I have a strong history and a proven track record of
leading or working with the team in quality auditing of domestic and international class I/III medical device products,
facilities and operations. I strive for continuous improvement, and Consistent Quality Assurance with reduced waste
while auditing, consulting, and contracting medical device facilities. This includes auditing, reviewing, and critiquing
all Validation/ Verification, protocol documentation, set up testing, build fixtures Define and Setup Quality Assurance
programs and train personal inhouse, and/or contractors, local and offshore while insuring a quality FDA QSR
and/or ISO certified build. I have participated in multiple projects to problem solve while working in the
government arena and as a medical device consultant. I have participated in and/or set up quality audit teams and
wrote team reports while in the government or as a consultant. Audited, reviewed, and critiqued FMEA’s, data and
ongoing design considerations. In all audit and consulting projects, I have demonstrated hands on expertise. These
skills have resulted in increased quality and operating integrity.
PROFILE
Medical Device Compliance professional with more then years of progressive experience, including experience in
metallurgical engineering. Extensive knowledge in project management, Failure Modes & Effects Analysis,
sociology, earth science and media productions. A diverse background in consulting, auditing, manufacturing, and
medical device operations, with experience in the medical device industry.
SKILLS
. Audit, review, and critique most lean related manufacturing technologies.
. Revise, prepare, audit, review and critique QA and QC programs and documentation to ensure quality
production.
. Provide QA Mfg and test support for Mfg floor and contract vendor production lines.
. Provide information and support for ongoing product design and new product design review boards.
. Audit, review and critique all QSM, SOP, EC related protocols and documentation.
. Audit, review and critique all IQ, OQ, PQ, PPQ related protocols and documentation.
. Audit, review and critique all QC Mfg related protocols and documentation.
. Audit, review and critique Risk Management program and deliverables FMEA’s, FTA’s, etc.
. Audit, review and critique manufacturing program procedures, sampling, and processes.
. Participate and represent Regulatory in Design and Manufacturing meetings. ECO, DRB, MRB, etc.
. Train and Qualify QA, Mfg, Test and Admin personnel related to the manufacturing and test processes.
. Work with ISO/EN/CE, FDA, and other Agency documentation and Qualifications.
. Revise, prepare, audit, review and critique Multilevel SOP, BOM, and ECO process instructions and records.
. Audit, review and critique SPC and QC/QA related protocol and documentation
. Skilled in New Product Introduction, NPI and ISO/ EN / certification processes.
. Audit, review and critique validation SOPs and policies according to cGMPs for aseptic process validation,
sterilization validation steam, gamma, EtO, dry heat, etc..
. Audit, review and critique Large and small vendors for setup and Transfer of products to vendor sites.
. Audit, review and critique schematics, blueprints and build instructions fort both Electrical and mechanical
devices
. Proficient in MAC/PC Applications: MS Windows, MS Office, Word, Excel, PowerPoint, etc.
. Audit, review and critique purchasing control records and operations
. Audit, review and critique Software and Hardware validation.
. Audit, review and critique Failure mode effect analysis of product design specifications and documentation.
. Monitor, maintain, audit, review and critique Corrective action and process document processes.
. Audit, review and critique Design review FMEAs and risk management for product design analysis.
. Audit all major test equipment such as scopes, logic analyzers, spectrum analyzers, etc..
. Audit all major production equipment such as CNC machines, packaging machines, sterilizers, etc..
REGULATORY EXPERTISE
All Types of Class I/III Medical Devices, Including Electronic, Mechanical, and Nonmechanical Medical Devices
Durable, Electronics, Implantables, IVDs, Lasers, Software, Cataract systems, Oncology systems, Coated Stents,
Steerable Catheters, Over the wire OTH, Rapid Exchange RX Stent delivery systems STS, Pacemakers,
Tracheostomy Tubes, Sterilized Devices, and Orthopedic Implants. Adverse Event Evaluation, Audits
Certification/Due Diligence/ GCP/ GLP / ISO/Quality System Inspection Technique QSIT/ Quality System
Regulation QSR, Clinical Labeling / Research/ Study design, Electronic Records & Electronic Signatures; CFR
Part , FDA, FDA and Warning Letter Responses/Consent Decree, GAMP, Hazard Analysis, ISO /
// / Risk Management/ Active Implantable Medical Device Directive AIMD / Invitro
Diagnostic Directive/ Medical Device Directive MDD, OSHA, , Quality Assurance, Quality Control, Quality
Management, Quality Systems Development/ Implementation, Working Knowledge of FDA Operations.
HIGHLIGHTS OF QUALIFICATIONS
Medical Device Compliance Results Oriented Problem Resolution
Failure Modes & Effects Analysis Strong Negotiation Skills Strategic Planning
Excellent Communication Skills Team Player and Leader Project Management
EMPLOYMENT HISTORY
June Present Confidential US Medical Device Manufacturer
CONTRACT MEDICAL DEVICE QUALITY EXPERT
• Conducts gap analysis of quality system using FDA laws and regulations.
• Assists with the development of quality control procedures and SOPs as required.
• Provides regulatory, quality, and technical expertise to top management and quality and operations
departments.
• Conducts training sessions related to regulatory, compliance, quality, and auditing to top management,
and to the quality and operations departments.
• Conducts internal audits of the quality system.
• Prepares written audit correction plan.
• Performs various audit correction activities, including revising written instructions, revamping the
document and change control, purchasing control, CAPA, and production and process control
operations.
June
ADB Consulting & CRO, Inc., Pembroke Pines, FL
CONTRACT MEDICAL DEVICE QUALITY SYSTEMS EXPERT
• Provides technical consulting to corporate, legal and government clients.
• Provides professional consulting as a FDA Medical Device Quality Systems Consultant.
Medical Device Client: Confidential, GLP Laboratory, USA
June
• Conducts gap analysis and initial qualification of GLP facility for USA SponsorMonitor of IDE
medical device using FDA laws and regulations.
• Provides regulatory and compliance expertise to top management and quality departments.
February Present Confidential Foreign/Non US Medical Device Manufacturer
CONTRACT MEDICAL DEVICE QUALITY EXPERT
• Conducts gap analysis of quality system using FDA laws and regulations.
• Assists with the development of quality control procedures and SOPs as required.
• Provides regulatory, quality, and technical expertise to the top management and quality,
engineering/R&D, and production departments.
• Conducts training sessions related to regulatory, compliance, quality, and auditing to top management,
and to the quality, engineering/R&D, and production departments.
• Conducts internal audits of the quality system.
• Prepares written audit correction plan.
• Performs various audit correction activities, including revising written instructions, revamping the
document and change control, purchasing control, CAPA, and production and process control

Cancel
Not Enough Credits
Sorry, but you don't have enough credits to download this resume.

Purchase more credits
Not Available
Sorry but this resume is not available for download. Please choose another!

Close
Confirm Download

Would you like to download  for 1 credit?

You have  credits left.

Yes No 

Don't ask me again
Confirm View Complete Resume

Would you like to view  for 1 credit?

You have  credits left.

Yes No 

Don't ask me again