MEDICAL DEVICES

• Foundation Medicine-SaMD Cancer Biomarker medical device AI software used by Oncologists
  • Compliance-review and approval of SaMD software verification documents per IEC62304  
  • Review of SaMD validation documentation
  • Generated a SDLC Gap Assessment per IEC62304
  • Wrote a Lean Agile SDLC to decrease cycle time, increase quality, and meet IEC62304 and ISO14971
• Bayer Radiology
  • Validated $10M SAL10 barrel linear and plunger linear computerized production equipment
  • Compliance work on injector software validations

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• Johnson and Johnson Cordis-Medical device validation-coronary stents and catheters
  • ​Performed 21 CFR Part 11 Validation for ERP JD Edwards system
  • Part of a team responsible for creation of J&J Cordis Validation methodology
  • Performed Software Quality Compliance of JD Edwards system per SDLC based on GAMP
  • Performed Vendor Site Audits, wrote the final reports for functional area senior manager   

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• Medtronics Heartware-Ventricular Assist Heart pump with embedded software
  • Due to an FDA warning Letter, performed gap assesments of validated systems   
  • Performed remediation validations for 85+ systems to align with revamped validation framework 

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• SIEMENS-Diagnostics
  • Validated Production spreadsheets

• Diasorin-Diagnostics
  • Performed validations for Lab Equipment and IT COTS and COTS Configured software
• Zimmer- Implants
  • ​Deployment Manager for CAPA Trackwise Module

• Orthosensor-Verasense
  • ​Product Maintenance QA Engineeer-Wrote, reviewed, and approved software and implant documentation 

• Abbott-Auto Assist glucose meter
  • ​Performed validation of ADC Advanced Auto Assist Apollo glucose meter clinical software

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• ​QA and Regulatory Director at DermaSensor-
  • Standalone medical device software Verification under IEC62304,TIR45, Software Guidance.Wrote Agile SDLC 
  • Validation of embedded software, CRM, IT systems 
  • Hardware Product Development, Design Controls, Verification and Validation,DHF, Design Transfer, DMR
  • Non-clinical tests coordination with labs. 
  • Usability/Human Factors study 
  • Labeling 
  • Prepared Modular PMA, DeNovo dossier. IDE, Breakthrough device 
  • MDR gap assessment, Technical File preparation for CE marking and product certification with TUV-SUD
  • Fielded product in New Zealand and Australia  

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• QA and Regulatory Director at MedTek   
  • ​SaMD, SiMD-Embedded Software verification under IEC62304, TIR45, Software Guidance. Wrote Agile SDLC
  • Validation of SaMD, Embedded Software 
  • Hardware Product Development, Design Controls, Verification and Validation,DHF, Design Transfer, DMR
  • Supplier Qualification
  • QMS Implementation under ISO13485, ISO14971, 21 CFR Part 820,11,CAPA,MDR,Complaints 
  • 510K  

 PHARMACEUTICALS​

• QA Manager at ANDRX Corporation-Distribution and IT systems QA.  Validated ERP non-product software, IT Software 
• Luitpold -Validated Lab equipment, Electron microscope, and COTS and COTS Configured applications 
• Noven-Validated $5M Seineader and Pester Serialization equipment  

OTHER WORK

Software Quality Assurance Director-QPay 

• Implementation of Software QA framework: SRS,Testing,RTM, Automation for Cellular Carrier Payment Platforms 

Department of Defense 

• CECOM (Communications and Electronics Command)
  • ​Sensors; electronic warfare and surveillance systems software development
• MICOM (Missile Command, Software Engineering Directorate) missile software testing 
  • PATRIOT-Phased Array Radar Intercept on Target anti-ballistic missile testing at White Sands Missile Range
  • MLRS-Multiple Launch Rocket System testing  
  • TOW-Tube Optically Wire Guided Missile testing

Gables Engineering -Avionic Panels 

• QA for BOEING and Airbus -TCAS (Traffic Collision and Avoidance), ILS (Instrument Landing), COMM, and others  ​​

Motorola Communication Systems and Infrastructure

• CMM Process maturity implementation and certification