Maria Eze
Raqa Manager @Medfor
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WORK HISTORY
Raqa Manager @Medfor
Aldershot, GB
Ensure product quality is upheld across the manufacturing process through regular audits, assessments, and implementation of continuous improvement initiatives.Lead the development and execution of the internal audit plan and coordinate preparations for external audits to maintain compliance with ISO 13485, MDR, and IVDR standards.Monitor and manage supplier quality through KPIs, audits, and improvement initiatives.Investigate and manage customer and supplier complaints, as well as CAPAs, to drive root cause analysis and corrective action.Provide quality input for product investigations, deviations, change controls, validation protocols/reports, and SOPs.Maintain and update technical documentation to ensure regulatory compliance.Support validation and ongoing compliance of ETO and gamma sterilisation processes.Lead updates to the Quality Management System in line with ISO 13485:2016 requirements.Develop and review product and process risk assessments.Chair Management Review Meetings and provide quality oversight at the leadership level.Secure regulatory approvals for product entry into new global markets.Oversee Pre-Market Clinical Follow-up (PMCF) and Post-Market Surveillance (PMS) activities.Ensure training records are up-to-date and compliant.Act as the Person Responsible for Regulatory Compliance (PRRC) under MDR.
EDUCATION
Anglia Ruskin University
Master of Science (MSc), Biomedical Sciences, General
University of East London
B.Sc. (Hons), Biomedical Science, Biomedical Sciences, General
SKILLS
ABOUT MARIA EZE
As a Quality Assurance (QA) and Regulatory Affairs (RA) professional, I am passionate about driving excellence in compliance, quality management, and regulatory frameworks within highly regulated industries. With extensive experience in leading Quality Management Systems (QMS) and ensuring adherence to global standards such as ISO 13485, ISO 9001, ISO 27001, and MDSAP, I have successfully guided organisations through complex audits and regulatory challenges.I specialise in streamlining processes, managing supplier assurance programs, and implementing data protection strategies, including GDPR compliance. My expertise spans across various regulatory frameworks, including UKMDR, IVDR, and FDA CFR21 Part 820, enabling me to support global product compliance and market access.A key part of my career has been fostering collaboration across teams, delivering impactful training, and embedding a culture of quality and continuous improvement. Whether it’s maintaining ISO certifications, leading audits, or supporting cross-functional projects, I am driven by the goal of aligning quality and compliance with business success.
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