Consultant, Auditor and Trainer
Deb Hoffman is a simpleQuE consultant and dedicated auditor with more than 15 years’ experience managing and conducting internal and external assessments. Deb spent 10 years in manufacturing and 6 years in Supplier Quality Assurance. She is a certified ISO 9001, ISO 13485, and AS9100 lead auditor.
ISO/Quality Management Systems
Deb is a proven Quality and Regulatory Affairs professional with 25+ years’ experience across all functions of quality management systems within the Aerospace, Medical Device, Pharmaceutical, and Defense Industries. She has created and managed Quality Management Systems, processes and procedures for AS9100, ISO 9001, ISO 13485, FDA GLP’s, and GMP’s. In addition, she has been responsible for:
- Developing and conducting training in support of QMS processes and procedures
- Developing and maintaining quality metrics and performance reporting
- Leading cross functional teams to complete quality improvement projects and drive standardization
- Managing and monitoring the internal audit program
- Corrective Action implementation, verification and management
- Supplier Management (Audits, Certification, Improvement Initiatives)
Currently, Deb conducts QMS audits for AS9100 and AS9120. She developed her aerospace experience as Senior Lead Internal Quality Assurance Auditor at Eaton Corp. Deb managed the annual internal quality audits/schedules for the manufacturing facility and led corporate customer and supplier site assessments. She hosted external audits for customers/government (FAA – QSA, DCMA), foreign entities (EASA, CAAC), and 3rd party inspections. Her responsibilities included auditing all facets of fuel pump and part manufacturing, including machining, assembly and test while supporting three quality managers and training/directing 10 quality auditors. In addition, Deb:
- Managed 90+ internal audits each year, monitoring quality assurance issues, assessing/prioritizing noncompliance risks, coordinating corrective action, writing reports, and providing key metrics to leadership.
- Ensured site OEM Quality Management System (QMS) and internal audits met FAA 14 CFR 21 and applicable orders.
- Oversight of site Repair Station QMS and Internal Evaluation Program (IEP) in accordance with FAA 14 CFR 145.
- Served as Corporate Aerospace auditor, providing support to Eaton North America Hydraulics/Aerospace Quality, re-writing Quality Manual and obtaining site AS9100 re-certification.
- Conducted internal audits to ensure conformance to major OEM customer requirements for Collins, G.E., Safran, Rolls Royce, and more.
- Served as special process auditor for areas including Anodize, NDT, Heat Treat/Nitride, Dry Film, and Shot-Peen.
Certificates and Training
- AS 9100:2016 Aerospace Auditor Transition Training
- ISO 9001/AS9100:2016 Certified Lead Auditor
- ISO 13485:2016 FDA 21 CFR 820 Lead Auditor Training
- Exemplar Global Qualification Based Lead Auditor – QMS Auditor
- Certified Manager of Quality / Organizational Excellence (ASQ)
- Certified Quality Auditor (ASQ)