Coleen Fox

Refines AI response content and style to improve readability, organization, and trustworthiness while mitigating bias and controversial topics for production ML outputs.

Developed and maintained GMP-ready quality protocols and inspection mechanisms to ensure ISO 9001/ISO 13485 compliance, coached manufacturing engineers on CAPA, and implemented data-driven process improvements to increase medical cart workflow efficiency.

Managed ISO 9001:2015-compliant quality systems for metal extrusion operations, executed CAPA and audits, applied FEA and data-driven analysis to improve reliability for a $5B customer, and updated SOPs to enhance process control.

Conducted gap assessments and risk analyses to harmonize global quality standards with MDR and FDA CFR requirements, supported material validation and corrective actions to enable market access.

Reviewed and updated Design History Files for multiple product lines to ensure compliance with EU Medical Device Directive and MDR, and supported design controls and regulatory documentation.

Executed FDA-compliant software validations (IQ/OQ/PQ) for enterprise projects, produced validation documentation and training materials, and supported verification efforts for a $20B company's shipping website.

Bachelor of Science in Engineering with a focus in Biomedical Engineering, covering engineering principles applied to medical devices and product development.