Overview
Job Title: QMS Training Specialist
Job Type: Permanent, Full Time
Location: Flexible onsite in Oxford
An innovative, fast-paced global medical device company with a mission to improve patient outcomes by advancing organ transplantation technologies is looking for a QMS Training Specialist. The role supports the design, delivery, and management of training programs to implement and maintain the Quality Management System (QMS) and ensure compliance with global regulatory requirements and quality standards, including ISO 13485 and FDA 21 CFR Part 820.
This is a hybrid position based in Oxford, with occasional travel (up to 10%) to other company locations in the UK and the US.
Responsibilities
* Reporting to the Manager of Audits and QMS Training, lead the development and implementation of QMS training strategies and materials aligned with regulatory requirements and company policies.
* Deliver induction and refresher training on QMS principles, procedures, and tools to employees across the organization.
* Maintain accurate and compliant training records in accordance with internal SOPs and applicable regulations.
* Evaluate the effectiveness of training through audits, assessments, and participant feedback.
* Collaborate with department stakeholders to identify training needs and assist in creating tailored content.
* Ensure all training materials reflect current regulatory standards and best practices.
* Support internal, customer, and regulatory audits by providing training documentation and demonstrating compliance.
* Facilitate continuous improvement initiatives related to QMS training and education.
* Lead the development and ongoing optimization of the Learning Management System (LMS), ensuring it supports scalability, user engagement, and regulatory adherence.
Requirements
* Bachelor's degree in Life Sciences or a related field, or equivalent combination of education and relevant industry experience.
* Minimum of 3 years' experience in quality systems training within a regulated industry such as medical devices, pharmaceuticals, aerospace, or automotive.
* Familiarity with device regulations such as FDA QSR, ISO 13485, ISO 14971, MDR, and MDSAP is a plus.
* Communication: Strong ability to clearly communicate technical and quality-related concepts to diverse audiences. Skilled in adapting content and style for varied learning needs. Excellent presentation skills required.
* Technical Proficiency: Experience with Microsoft Office, LMS platforms, SCORM, xAPI, and e-learning development tools. Familiarity with electronic QMS (eQMS) systems is advantageous.
* Other Skills: Detail-oriented with strong organizational and analytical abilities. Able to prioritize, multi-task, and work effectively both independently and within a team.
Preferred Qualifications
* Experience in designing or delivering training programs inclusive of neurodivergent learners, with a focus on accessible and adaptive training methodologies.
#J-18808-Ljbffr