Job Title: Internal Auditor - QMS Location: Oxford, UK
Job Type : Permanent - Full time
As part of its continued growth, a dynamic and global medical device organization are seeking a meticulous and organized Internal Auditor – QMS to join its team. The Internal Auditor – QMS is responsible for conducting internal audits across global sites to ensure compliance with company policies, quality standards, and applicable regulations. The ideal candidate will possess excellent attention to detail, strong organizational abilities, and a background in conducting thorough, value-added audits that support ongoing quality system improvements. This role is vital for ensuring that company operations align with the Quality Management System (QMS).
Conduct internal audits to ensure compliance with FDA 21 CFR Part 820, ISO 13485, EU MDR, and other applicable standards.
Evaluate organizational processes against defined quality standards.
Perform risk assessments and analyze audit outcomes to detect trends or systemic issues.
Prepare and present detailed audit reports to management.
Support development and implementation of corrective action plans based on audit findings.
Provide training and guidance to staff regarding quality standards and QMS principles.
Stay informed on the latest developments in relevant quality standards and regulations.
Comply with the company’s Code of Conduct and all other corporate policies.
University or college degree, preferably in a scientific or quality/regulatory discipline.
Minimum of 3 years of experience in medical device quality auditing, or a comparable combination of education and experience
In-depth knowledge of medical device regulations including FDA QSR, ISO 13485, ISO 14971, EU MDR, MDSAP, and CMDR.
High emotional intelligence and professional demeanor to ensure positive engagement with auditees during audits.
Proficiency in Microsoft Office tools (Excel, PowerPoint, Visio, Word, Access).
Experience in quality audits preferred; lead auditor certification in ISO 13485, MDR, or MDSAP is an asset.