Education / Educación:
Technical bachelor’s degree. Experience / Experiencia:
8 plus years’ experience preferably in medical device industry. Experienced with FDA Quality System Regulations, ISO 13485, MDSAP, Medical Device Directive and Medical Device Regulation.
Summary of Duties and Responsibilities / Resumen de funciones y responsabilidades:
Responsible for the NCE program including managing divisional non conformances through the lifecycle, publishing status reports, and hosting MRB review board meetings. Ensure consistent application of NCE processes across sites and manufacturing partners. Support escalation and investigation of significant nonconformances impacting product quality or regulatory compliance. Mentor NCE owners in the investigation, documentation, root cause analysis, resolution and escalation of nonconformities. Ensure alignment of the NCE process with QMSR and ISO 13485 requirem...