Quality Systems Consultant Resume

SUMMARY

35 years combined experience in quality / design assurance from the defense, aerospace, commercial and medical device industries. Specialized in hybrid microelectronics and medical device (ICD/Pacemaker) design, materials, manufacturing equipment / processes and inspection requirements / methods
Extensive background in quality assurance operations with hands - on management responsibilities in customer driven, high technology, CGMP / QSR compliant and ISO 9001 / ISO 13845 team environments
12 Marathons and several high altitude glacier mountaineering successes to date

PROFESSIONAL EXPERIENCE

Confidential

Quality Systems Consultant

Responsibilities:

Review of device manufacturing / design history records and test data for compliance to Federal and International Standards
Delegation of industry experts for investigation/follow-up of defective Implantable Cardioverter Defibrillators (ICD’s), Pacemakers, Nero-modulation, Deep Brain stimulation and Drug Infusion Pump devices
Delegate industry experts within their respective areas of expertise for DMDCG contract activities

Confidential

Design Assurance Engineer

Responsibilities:

Identified critical design input features using field return and manufacturing data. Established product qualification test requirements, design outputs, schedules for product development in conjunction with R & D, Process Engineering, Supplier Quality Assurance, Regulatory Affairs, Manufacturing and other service groups. Developed and implemented Design Assurance / Qualification Test Protocols (QTP/R) for component, subassembly and device performance evaluation for ICD’ and Pacemakers as intended for human implant:
Evaluation of malfunctioning ICD devices from the field. Implemented and documented design / manufacturing Root Cause Analysis and CAPA. Reported monthly status / results to Corrective Action Board
Analysis of QTP results / anomalies and implementation of corrective actions
Participated in FMEA’s for new ICD and Pacemaker design efforts
Member of the Change Control Board (CCB) for all ICD related changes
Developed / implemented inspection criteria / instructions and training per MIL-STD-883, IPC 600 / 610, at SJM, supplier and off-shore manufacturing facilities.
Performed Installation, Operational Qualifications (IQ / OQ) and final product qualifications of supplier and SJM equipment, processes and inspection methods.
Generation of final QTR’s for the FDA, 501K submission process
Participated in, and assisted Regulatory personnel and the FDA regarding qualification / validation questions and issues
Daily interface with Design and Manufacturing Engineering groups regarding design requirements and manufacturability
Participated in all ICD component, subassembly and device MRB meetings for interpretation of inspection / test results and follow-up actions
Daily QAE support to ICD manufacturing / inspection operations regarding process and / or inspection requirement questions / clarifications:
Review and disposition of all manufacturing non-conformances
Clarify acceptance criteria and conduct Operator / Inspector training as required.
Saved over $500,000.00 in annual scrap costs and increased yields in manufacturing with design / process revisions of problematic components using Six Sigma techniques
Mentored Co-op students, junior engineers and colleagues in supplier control, process / equipment verification / validation and manufacturing operations
Successful transfer of ICD operations to Puerto Rico (PR) and Malaysia facilities:
ICD and Pacemaker equipment Installations / Operational Qualifications (IQ / OQ) and final product qualifications:
Daily (24/7) support to PR and Malaysia operations

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