Job Title: Senior / Lead Auditor
Location: Oxford, Hybrid
Job Type: Permanent Full Time
A global leader in medical device innovation, dedicated to advancing transplant technology and improving patient outcomes, is seeking a highly skilled
Senior Auditor – Quality Management Systems (QMS)
. This senior-level role is responsible for planning and executing a full spectrum of audits: internal, external, and supplier across global sites. The Senior Auditor ensures compliance with international medical device regulations, company standards, and the Quality Management System (QMS), while also driving continuous improvement initiatives. The successful candidate will be an experienced, certified auditor with deep knowledge of global medical device regulations, including FDA, EU MDR, and MDSAP.
Responsibilities
* Plan, lead, and execute internal, external, and supplier audits across international operations.
* Ensure compliance with FDA 21 CFR Part 820, ISO 13485, EU MDR, MDSAP, and other applicable regulatory frameworks.
* Evaluate processes against quality standards, identifying risks, gaps, and opportunities for improvement.
* Perform risk-based audit assessments, analyze findings, and identify systemic or recurring issues.
* Develop, communicate, and present clear and comprehensive audit reports to senior leadership and stakeholders.
* Collaborate with internal teams and external partners to develop and verify the effectiveness of corrective and preventive action (CAPA) plans.
* Provide expert training and guidance on QMS requirements, audit readiness, and regulatory expectations.
* Monitor regulatory updates and proactively integrate changes into the QMS audit program.
* Uphold the company's Code of Conduct and foster a culture of quality, compliance, and continuous improvement.
Requirements:
* Bachelor's degree in a scientific, engineering, quality, or regulatory discipline (or equivalent experience).
* Minimum of 5 years of experience in quality auditing within the medical device industry, including supplier audit management.
* Certified lead auditor with recognized qualifications in
MDSAP
and/or
ISO 13485
(required).
* Strong working knowledge of global medical device regulations, including FDA QSR, EU MDR, ISO 14971, and CMDR.
* Demonstrated success leading internal, external, and supplier audits across diverse geographies.
* Excellent communication and interpersonal skills with the ability to influence and engage stakeholders at all levels.
* High emotional intelligence and professionalism, ensuring positive and constructive engagement with auditees.
* Strong analytical, problem-solving, and organizational skills, with a focus on driving sustainable improvements.
* Proficiency in Microsoft Office Suite (Excel, PowerPoint, Visio, Word, Access).
* Experience managing complex audit programs; additional certifications (e.g., MDR auditor qualification) are a strong asset.
Please reach out to for further information.