Years of experience: 26

Data EntryConsultingAssociateComputer engineerEngineer

Trust Score

Highly reliable; strong professional involvement.

70%
Michael's Career Path
Quality Engineering Consultant - Medical DevicesOct. 2024 -
Present
Various Med Dev CompaniesQuality Engineering Consultant - Medical Devices
Seacoast 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 Supp...
Senior Quality EngineerNov. 2019 -
Oct. 2024
Neutron Therapeutics, LLCSenior Quality Engineer
Danvers, 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 assess...
Quality EngineerApr. 2011 -
Nov. 2019
ProTom InternationalQuality Engineer
Wakefield, 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...

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