Job Description
Job Title: Internal Auditor - QMS
Location: Oxford, UK
Job Type: Permanent - Full time
Position Summary
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. They are dedicated to improving lives through advanced transplant technology.
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).
Responsibilities:
1. Conduct internal audits to ensure compliance with FDA 21 CFR Part 820, ISO 13485, EU MDR, and other applicable standards.
2. Evaluate organizational processes against defined quality standards.
3. Identify areas for improvement and propose corrective actions within the QMS.
4. Perform risk assessments and analyze audit outcomes to detect trends or systemic issues.
5. Prepare and present...