Garrett “Gus” Rathgeber, PhD

Consultant - Quality Management & Regulatory Compliance

Gus is a Quality Assurance professional with 39 years of industry experience, along with industry recognized certifications and related advanced education. During his tenure in industry, Gus performed roles with increasing levels of responsibility that included Chief Operating Officer for a manufacturer of Medical Devices and Aerospace components.

Presently Gus provides technical consulting services to the medical device, pharmaceutical, biologic, cosmetics, aviation, space, and defense industries. His client services focus on conformity to Quality standards, compliance to regulatory requirements, and implementation of actions for problem resolution and/or improvement. Gus has a passion for educating people by advancing their knowledge in his areas of expertise.

Gus holds a Doctor of Management in Organizational Leadership from the University of Phoenix, an M.S. in Management & Administration from West Chester University and a B.S. in Industrial Engineering Technology from Eastern Kentucky University.

Certifications
Aviation, Space & Defense
Probitas Certified Lead Auditor

  • AS9100D
  • ISO 9001:2015

Medical Device
Exemplar Global Certified Lead Auditor

  • ISO 13485 With FDA 21 CFR 820
  • Medical Device Lead Auditor
  • EU MDR

Pharmaceutical & Cosmetics
(RAPS) Regulatory Affairs
Professional Society

  • Certified Medical Device Reg

Other Certifications
CMMI Lead Assessor – Pyxis Systems Int’l
Certified Quality Auditor – ASQ
Project Management Professional – Lockheed Martin
Lean – Six Sigma Black Belt – Lockheed Martin
Microsoft Certified Professional – Herzing College
Empowered Workforce Certified Instructor – Lockheed Martin

Certificates
ISO 13485:2016 with FDA 21 CFR 820 Lead Auditor
EU-MDR Certified Auditor
AS9100D Lead Auditor
Medical Device Lead Auditor

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