Jeff vander Hoek

Background

About Jeff vander Hoek

With over 32 years of progressively greater responsibilities in the Medical Device Quality Assurance and Regulatory Field, I know I have what it takes to develop and maintain an FDA and ISO 13485 compliant Quality and Regulatory Assurance System. My goal is to use my experience to grow and improve the Quality and Regulatory systems of whatever company I am at into the best they can be. Certified as an ASQ CQE, and trained as an ISO 13485 internal auditor, there is nothing I cannot handle. Specialties: Trained & Experienced in Developing & Directing FDA and ISO 13485 compliant Quality Systems, as well as overseeing & /or performing: CE mark & IDE submissions, Device Registrations, Validations, ISO 14971 Risk Management Reviews, Audits (internal & external), Failure Analysis, CAPAs, and Statistical Analysis.