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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 are looking for a QMS Training Specialist. Founded as a university spin-out in 2008, they are now a commercial-stage organisation recognized for developing groundbreaking solutions that support organ viability and transplant success.
As part of our continued global growth, we are seeking a knowledgeable and detail-oriented QMS Training Specialist to lead the design, delivery, and management of training programs supporting the implementation and maintenance of our Quality Management System (QMS). This role is vital to ensuring compliance with global regulatory requirements and quality standards, including ISO 13485 and FDA 21 CFR Part 820, as well as supporting our internal quality objectives.
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, the QMS Training Specialist will be responsible for:
* Supporting the development and implementation of QMS training strategies and materials aligned with regulatory requirements and company policies.
* Delivering induction and refresher training on QMS principles, procedures, and tools to employees across the organization.
* Maintaining accurate and compliant training records in accordance with internal SOPs and applicable regulations.
* Evaluating the effectiveness of training through audits, assessments, and participant feedback.
* Collaborating with department stakeholders to identify training needs and assist in the creation of tailored content.
* Ensuring all training materials reflect current regulatory standards and best practices.
* Supporting internal, customer, and regulatory audits by providing training documentation and demonstrating compliance.
* Facilitating continuous improvement initiatives related to QMS training and education.
* Leading 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.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance
* Industries
Medical Equipment Manufacturing
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