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

As part of our ongoing global expansion, we are seeking a knowledgeable and detail-oriented QMS Training Specialist to lead the development, delivery, and management of training programs that support the effective implementation and maintenance of our Quality Management System. This role plays a critical part in ensuring compliance with regulatory requirements, industry standards (such as ISO 13485, and FDA 21 CFR Part 820), and our internal quality objectives.


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 exhaustive.


This is an office based role in our Oxford location, with flexibility. Occasional travel of up to 10%, which may include visits to other organizational sites across the UK and the US, is expected in this role.

Major Responsibilities

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

Support the development and implementation of training strategies and materials related to QMS policies, procedures, and regulatory requirements. Conduct inductions and refresher training for all employees on QMS principles, processes, and relevant tools. Maintain training records in accordance with regulatory requirements and internal SOPs. Monitor and evaluate the effectiveness of training programs through assessments, audits, and feedback Collaborate with other department members to identify training needs and support the trainer with the creation of custom content. Ensure alignment of training materials with the latest updates in quality standards and regulatory guidelines. Support audits (internal, customer, and regulatory) by providing training records and demonstrating compliance Facilitate continuous improvement initiatives related to QMS Lead the development, customization, and continuous improvement of the Learning Management System (LMS) to ensure scalability, user engagement, and regulatory compliance Adhere to the letter and spirit of OrganOx's Code of Conduct and all other company policies

Requirements

Skills & Experience

3+ years of experience in quality systems training, particularly in developing training content and facilitating training sessions in a regulated industry (e.g., medical device, pharma, aerospace, automotive) Knowledge of device regulations such as FDA QSR, ISO 13485, ISO 14971, Medical Devices Regulation (MDR), MDSAP is advantageous Exceptional ability to convey complex or technical concepts in a clear, accessible manner tailored to diverse audiences; skilled in adapting communication style to ensure understanding across varying levels of knowledge, roles, and learning needs. Excellent presentation skills. Proficient in Microsoft Office applications and training tools/software, including LMS platforms, SCORM, xAPI, PowerPoint, and e-learning authoring tools; prior experience with electronic Quality Management Systems (eQMS) is preferred. Strong organizational and analytical abilities with a problem-solving mindset, detail-oriented, able to multi-task and prioritize responsibilities. Able to work independently and collaboratively. Experience designing or delivering training programs tailored to neurodivergent individuals, with an understanding of inclusive learning strategies and best practices is preferred.

Qualifications

Bachelor's degree in Life Sciences, or a related field; or an equivalent combination of education and relevant industry experience.

Benefits

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.