Damien Decrausaz

Quality Assurance Manager @Spectrum Assembly, Inc

Ensures compliance with AS9100, ISO 13485/ISO 9001, 21 CFR Part 820, and EU MDR medical device requirements. Coordinates and hosts ISO certification audits, client audits, and regulatory inspections. Leads and conducts internal audits of the quality system and manufacturing processes. Leadership and technical support to the Quality Department. Oversees the inspections of raw materials, in process materials, and finished products. Responsible for the generation and review of Device History Records. Leads investigations of non-conforming material and corrective action activities. Conducts process improvement projects.