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. As part of our global expansion, we seek a meticulous and organised Internal Auditor – QMS to join our team.

Position Summary

The Internal Auditor - QMS is responsible for performing internal audits at our locations globally to ensure compliance with company policies, industry standards, and legal requirements. The ideal candidate will have excellent attention to detail, strong organizational skills, and experience with in-depth value-added audits leading to a strong compliance foundation and improving our Quality Management System.

The ideal candidate will have a strong background in ideally medical device regulations and quality standards. This role is crucial for ensuring that all company practices are in accordance with the Quality Management System.

This is a full time, onsite role located at OrganOx’s US headquarters in Madison, NJ. Possible travel to the UK required.

Major Responsibilities

Under direction from the Manager, Audits & QMS Training, the Internal Auditor – QMS will be responsible for:

• Conduct Internal Audits: Perform regular audits of the QMS to ensure compliance with FDA 21 CFR Part 820, ISO 13485, EU MDR, and other relevant regulations.
• Evaluate Processes: Review and evaluate the organization's processes and systems against defined quality standards.
• Identify Improvements: Identify gaps and areas for improvement within the QMS and propose corrective actions.
• Risk Assessment: Conduct risk assessments and analyze audit results to identify trends or systemic issues.
• Report Findings: Create comprehensive audit reports and present findings to management.
• Corrective Actions: Help develop and implement corrective action plans based on audit findings.
• Training: Train and guide staff on quality standards and the importance of a QMS.
• Monitor Implementation: Monitor the implementation of corrective actions and verify their effectiveness.
• Stay Updated: Stay up-to-date with the latest quality standards and regulations.

Requirements

Skills & Experience

· Strong knowledge of device regulations such as FDA QSR, ISO 13485, ISO 14971, Medical Devices Regulation (MDR), MDSAP, and Canadian Medical Device Regulations (CMDR). Knowledge of other regulations and upcoming changes would be advantageous.

· Excellent analytical abilities, attention to detail, and experience with process improvement.

· Ability to effectively present information to management and respond to enquiries from customers, suppliers, and business partners.

• An internal auditor must be proactively aware of the impact an audit has upon auditees, to anticipate reactions and deal professionally with all situations. The position requires emotional intelligence to proactively communicate the value of the audit process and ensure auditees are comfortable answering questions.
• Proficient in Microsoft Office applications such as Excel, PowerPoint, Visio, Word, and Access.
• Organized, detail-oriented, and able to multi-task and prioritize responsibilities.
• Experience in quality audits preferred, Lead auditor certification desired in ISO-13485, MDR, MDSAP.

· Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies.

Qualifications

· Bachelor's Degree, or the equivalent work experience, preferably in science in quality/regulatory or related field.

· Minimum 3 years of experience, ideally in medical device quality system auditing or equivalent combination of education and experience.

· Ability to travel 10–15% annually, primarily across the US, UK, and Europe.

#LI-Onsite

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.

Benefits

The Pay Range for this position is $115,000 - $125,000 annually, with a 10% target annual bonus and benefits.

At OrganOx, we value bold thinkers who put customers first, while always exhibiting respect for all and passion in what they do. We offer competitive compensation and comprehensive benefits available from day one, including health, dental, vision, disability coverage, and flexible spending accounts. Additionally, we offer a 401(k)-retirement plan with company matching after 90 days, paid time off, holidays, and additional leave benefits, as well as employee discounts and access to our onsite wellness facility. OrganOx supports work-life balance and provides opportunities for ongoing professional development.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.