Carmen E. G.

WORK HISTORY

EDUCATION

SKILLS

ABOUT CARMEN E. G.

Quality and Regulatory professional with experience across medical devices and regulated manufacturing environments, supporting Quality Management Systems (QMS), audit readiness, complaint handling, CAPA and regulatory compliance under EU MDR, ISO 13485, ISO 14971 and FDA-aligned quality systems.My work focuses on ensuring quality systems operate effectively in practice, including end-to-end complaint management, post-market surveillance, SOP and work instruction development, audit preparation, training and cross-functional process improvement. I have experience supporting Notified Body audits, responding to BSI queries and preparing audit-ready documentation and evidence.I apply risk-based decision making in complaints, CAPA and product performance evaluation, working with risk tools and documentation including dFMEA and pFMEA. A key strength is translating complex quality and regulatory requirements into clear, structured documentation, guidance and training, helping teams understand what “good” looks like in practice and apply it consistently across the organisation.I am interested in opportunities where quality, regulatory compliance, process improvement and clear communication contribute to effective, practical and audit-ready quality systems.