Quality Auditor

OrganOx; Oxford; On-site; GBP 35,000 - 55,000; Full time

Job summary

A leading medical device company in Oxford is seeking a Quality Auditor to lead internal and supplier audits, ensuring compliance with industry standards and enhancing operational excellence. The role requires a strong understanding of medical device regulations and significant auditing experience. The ideal candidate will drive continuous improvement initiatives across the organization while fostering strong relationships with suppliers.

Benefits

Competitive compensation

Comprehensive benefits including healthcare and retirement plans

Support for work-life balance

Opportunities for ongoing professional development

Qualifications

• Minimum 3 years of experience in medical device quality system auditing or equivalent combination.
• Lead auditor certification desired in ISO-13485, MDR, MDSAP.

Responsibilities

• Plan and conduct internal and supplier audits in compliance with OrganOx quality agreements.
• Evaluate quality management system processes and supplier performance.
• Support new supplier evaluations and participate in external inspections.

Skills

Knowledge of medical device standards and regulations

Analytical abilities

Attention to detail

Critical thinking skills

Interpersonal Skills

Technical Proficiency

Organizational Skills

Audit Experience

Education

University or College degree in sciences or quality/regulatory

Tools

Microsoft Office

Job description

ABOUT ORGANOX:

OrganOx is an innovative, fast-paced, global medical device company with a mission to save lives by making every donated organ count. We are a commercial stage organ technology company, spun out of the University of Oxford in 2008, committed to improving transplantation outcomes throughout the world. The company’s first product, the OrganOx metra normothermic machine perfusion (NMP) system for liver transplantation, has been used to support more than 5,000 liver transplant operations globally.

Position Summary

The Quality Auditor is responsible for lead and execute internal audits across our sites and conduct supplier audits to ensure Organox products are safe & effective, verify full alignment withour Quality Management System, regulatory requirements, and industry best practices.

You will be instrumental in identifying process improvement opportunities and driving continuous improvement initiatives throughout the organization and our supply chain.

The ideal candidate brings deep knowledge of medical device regulations including FDA QSRs and the EU Medical Device Regulation, ISO 13485, and , along with a proven ability to conduct value-added audits that go beyond compliance to strengthen operational excellence.

Listed below are the major responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally exhaustive.

This is a flexible on-site position in based in our Oxford office, with a minimum of 10% travel across the UK and Europe to visit Organox and supplier sites.

Major Responsibilities

Under direction from the Manager, Audits and QMS Training, the Quality Auditor will be responsible for:

• Plan and conduct internal and supplier product and manufacturing audits in accordance with Organox quality agreements, regulatory requirements (e.g., ISO 13485:2016, FDA 21 CFR Part 820, EU MDR).
• These audits will be completed to a defined schedule which will require high level planning skills to ensure on-time completion and reporting.
• Evaluate quality management system processes and supplier performance to ensure ongoing compliance and effectiveness.
• Identify areas for improvement within the QMS and supplier systems and support the implementation and verification of corrective actions.
• Develop and deliver audit reports, communicate findings to management, and monitor the effectiveness of corrective measures.
• Corrective Actions: Help development and implementation of corrective action plans based on audit findings.
• Support new supplier evaluations, to ensure quality agreement requirements are met, determine approval, and re-evaluations through audit and quality assessment activities.
• Participate in and support external inspections and audits (e.g., BSI Notified Body, FDA).
• Foster strong working relationships with suppliers to drive continuous improvement and compliance.
• Stay current with changes in applicable quality regulations and standards, providing training and guidance to internal teams as needed.
• Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies

Skills & Experience

• Strong knowledge of medical device standards and regulations such as FDA 21 CFR part 820 , ISO 13485, ISO 14971, Medical Devices Regulation (MDR) 2017/745, MDSAP. Knowledge of other relevant regulations and upcoming changes would be advantageous.
• Excellent analytical abilities, attention to detail, critical thinking skills, and experience with process improvement.
• Ability to actively listen, effectively present information to auditees management and respond to enquiries from customers, suppliers, and business partners.
• Strong Interpersonal Skills: The Internal Auditor we are looking for is able to build rapport with auditees, able to anticipate reactions and deal professionally with all situations, able to create a positive, and respectful audit environment. This role requires emotional intelligence and the ability to communicate the value of audits, making stakeholders feel at ease while encouraging open dialogue and collaboration.
• Critical Thinking & Continuous Improvement mindset: We're looking for an auditor who thinks beyond checklists — Someone who can look at processes end-to-end, ask the right questions, and spot practical ways to improve efficiency, compliance, and overall performance—benefiting both quality and business outcomes.
• Technical Proficiency: Proficient in Microsoft Office applications such as Excel, PowerPoint, Visio, Word, and Access, knowledge of Master Control is advantageous
• Organizational Skills: Organized, detail-oriented, and able to multi-task and prioritize responsibilities
• Audit Experience: Experience in quality audits preferred, Lead auditor certification desired in ISO-13485, MDR, MDSAP

Qualifications

• University or College degree, preferably in sciences or quality/regulatory, or equivalent combination of education and experience.
• Minimum 3 years of experience in medical device quality system auditing or equivalent combination of education and experience.

A job description does not imply that the duties stated are the only ones to be performed by the job holder. Job holder will be required to follow any other job-related instruction as reasonably requested by their line manager or their designate.

At OrganOx, we value innovation, evidence, integrity, teamwork, respect, and passion. We offer competitive compensation and comprehensive benefits, including healthcare and retirement plans. We support work-life balance and provide opportunities for ongoing professional development.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, sex, sexual orientation race, or any other characteristics protected by law.