Thom Hoffman

Quality & Compliance Strategic Advisor

Jacksonville, Florida, United States

About

I started my journey in Quality many years ago with the United States Navy. After being sufficiently salted (and honorably discharged) by the Navy, I had various Quality roles with General Electric, Johnson & Johnson and Medtronic, ultimately moving on to help other businesses solve problems, learning from eachother & sharing perspectives & ideas I've experienced over roughly four decades. To steal shamelessly from the Farmers Insurance commercial: 'We know a thing or two - because we've seen a thing or two...'. Throughout my career I have been an Auditor, Engineer, Managed Reliability/ Durability, Metrology and Metallurgy Laboratories, Product & Process Inspections teams, Supply Chain & Incoming Inspection teams, Quality & Environmental Audit Programs, CAPA teams, as well as other various roles. Over the years I've picked up some interesting & diverse compliance specific skills and spend a portion of my time coaching/ mentoring colleagues and associates. My background includes SSBB training, completing the Reid & Associates – Interviewing & Interrogation Techniques, Lead Auditor qualifications across industries for; ISO9001, ISO/TS16949 (Automotive), ISO14001 (Environmental), AS9100 (Aerospace), ISO13485 & 21CFR820 (Med Device), and have obtained various professional certifications, such as, ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), and the Certified Biomedical Auditor (CBA), and am well versed with MDSAP, and specific US, Ireland, Canada, Japan, Brazil, China, Australia, and Korean regulations. Additionally, represented MDT with ISO/TS 210 (Working Group 01), and have been involved with the development of ~20 published ISO standards, most recently ISO 13485, 3rd revision.

Experience

  • Quality & Compliance Strategic Advisor at Quality Compliance DNA
    Nov 2023 - Present · 2 yrs 8 mos

    Providing organizations w/40 yrs of Quality & Compliance perspective. Bringing fresh eyes to solve problems & drive opportunites home.

  • Medtronic (16 yrs 10 mos)
    • Lead Auditor (Regulatory, Compliance Specialist)
      Mar 2007 - Dec 2023 · 16 yrs 10 mos

    • Quality Compliance - Enterprise Regulatory Lessons Learned Program Lead
      Jun 2016 - Apr 2023 · 6 yrs 11 mos