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Work Background
Various Med Dev CompaniesQuality Engineering Consultant - Medical Devices
Oct. 2024Seacoast Region County, New Hampshire, United States• Authored work instructions and ensured ISO 13485 compliance for various Med Dev Companies in the Seacoast Region County, NH and N.E. Massachusetts areas.
• Quality Control product sign-off, resolved customer complaints, and participated in product nonconformance, CAPA and risk analysis resolution.
• QMS involvement including Incoming Inspection, New Product Development, Doc Control and Supplier approvals ensuring efficient and effective quality processes.
Neutron Therapeutics, LLCSenior Quality Engineer
Nov. 2019 - Oct. 2024Danvers, Massachusetts- Develops Boron Neutron Capture Therapy (BNCT) neutron beam-based cancer treatment systems -
● Manage NCR, CAPA, Calibration, Inspection (via GD&T), Doc. Control, and suppliers via SolidWorks PDM
● Maintained suppliers through their QMS per FDA QSR & ISO 13485/ISO 14971/ISO 9001 requirements
● Author of SOPs, Work Instructions, Test Procedures, Verification/Validation documents & risk assessments
● Integral team member in building, installing & validating 3 oversea $20M BNCT cancer treatment centers
ProTom InternationalQuality Engineer
Apr. 2011 - Nov. 2019Wakefield, MA- Develops and manages synchrotron-accelerated proton beam-based cancer treatment systems -
● Created SOPs, WIs, Risk Assessments, Assembly, Installation, Test, Setup and Servicing documentation
● Internal & supplier auditing of QMS processes per FDA 21CFR820 & ISO 9001/13485 requirements
● Managed NCR, CAPA, Supplier, Inspection, Calibration and Doc. Control depts. via PTC & Arena PLMs
● Key team member building/installing/validating 2 US $25M+ proton beam cancer treatment systems
CovarisQuality Engineer
Nov. 2009 - Mar. 2011Woburn, Massachusetts, United States- Develops high power, focused-ultrasonic systems for CSI & other molecular-level diagnostic uses - ● Created, qualified & executed bench and system-level testing for new & existing ultrasonic products
● Performed investigatory testing, inspections, & vendor qualifications as QA MRB committee member
● Risk assessment, troubleshooting, & root cause analysis on electronic systems, PCBs, & Components
ESA Biosciences (now Dionex and Magellan Diagnostics)Quality Engineer
Apr. 2008 - Jul. 2009Chelmsford, MA- Develops High-Performance Liquid Chromatography [HPLC] and blood-lead detection systems -
● Assisted new product designs, risk assessments & design verification/validation testing for R&D/MFG
● Managed ECOs, calibration, training, complaints, NCR and CAPA systems via Oracle Enterprise ERP
● Mitigated supplier defects 50% via supplier corrective actions (SCAR) as QA MRB committee member
OmniSonics Medical TechnologiesQuality Engineer / Test Laboratory Manager
Dec. 2005 - Nov. 2007Wilmington, Massachusetts, United States- Develops ultrasonic catheter-based technology used in treating Arterial and Venous Thrombosis -
● Performed design verification, validation, risk analysis, & EMC testing for Quality, R&D/Manufacturing
● Managed ME/EE laboratory personnel and performed medical equipment qualifications (IQ/OQ/PQ)
● Reduced open issues by 75% as Manager of the Corrective and Preventative Action (CAPA) committee
RSA SecurityQuality Engineer
Oct. 2004 - Sep. 2005Woburn, Massachusetts, United States- Develops identity, authentication, and access solutions for ultra-secure organizations -
● Performed hardware and software-based security identity token testing, verifications, and validations
● Created and qualified testing fixtures & equipment for use in controlled laboratory test environments
● Pre-screened & agency-lab tested security tokens for EMC, Safety, Shock, Drop, HALT/HASS testing
Abbott Diabetes Care (formerly MediSense)R&D Lab Manager/Engineer II
Mar. 1998 - Oct. 2004Bedford, Massachusetts, United States- Develops blood-glucose test devices and systems for diabetics and hospital patient purposes -
● Created medical device test fixtures, procedures and V&Vs for R&D, QA, & MFG per ISO 13485/17025
● Pre-screened ASIC integrated medical device metrology products for EN 60601-1, FCC, FDA, and UL
● Hired and supervised electrical, mechanical, and environmental R&D laboratory engineering personnel
● Managed inventory, test equipment and resources to maintain efficient laboratory operations
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