Accomplished professional with extensive expertise in medical device maintenance and quality management systems, including ISO 13485 and ISO 9001. Demonstrates proficiency in EU MDR, MDSAP, and regulatory compliance, ensuring adherence to industry standards through effective internal auditing and CAPA review. Skilled in process improvement, change management, and risk management, with a strong background in electrical and electronics engineering. Proven ability to lead audits and manage projects with exceptional stakeholder management skills. Committed to delivering high-quality results through detail-oriented documentation review and technical report writing. Career goals include advancing regulatory compliance strategies within the medical device sector while fostering team collaboration in remote work environments.