Back to Job SearchROLE OVERVIEW
We are currently looking for a QMS Sub System Lead – Training to join a leading medical device company supporting ongoing and upcoming projects in the US. This is an exciting opportunity for a professional with a strong background in quality management systems and training within regulated environments to contribute to a key remediation initiative. The role offers the chance to lead critical activities that ensure compliance and continuous improvement in training processes across global operations.
In this role, you will act as the Subject Matter Expert (SME) for quality training processes, guiding system design, regulatory adherence, and best practices. You will lead the training workstream within the QMS remediation program, addressing gaps and strengthening training systems to meet evolving standards. This will include supporting CAPA investigations, developing sustainable corrective actions, and implementing interim controls to sustain compliance during the transition.
KEY DUTIES AND RESPONSIBILITIES
Your duties as the QMS Sub System Lead – Training will be varied however the key duties and responsibilities are as follows:
• Serve as the SME for Quality Training processes, providing expertise in system design, regulatory expectations, and industry best practices.
• Lead the Training Workstream within the QMS remediation program, addressing compliance gaps and improving training systems.
• Support CAPA investigations, root cause analysis, risk assessments, and develop corrective and preventive actions.
• Implement and monitor interim controls and risk mitigation measures during remediation activities to maintain compliance until permanent solutions are in place.
• Lead or support the redesign and implementation of training procedures, systems, and records aligned with global regulatory requirements.
• Develop and maintain metrics, dashboards, and reporting tools to track remediation progress, training effectiveness, and identify continuous improvement opportunities.
• Provide training, mentorship, and cross-functional guidance to promote a culture of quality and compliance.
• As the QMS Sub System Lead – Training, you will ensure training processes support the organization’s quality objectives and regulatory commitments.
ROLE REQUIREMENTS
To be successful in your application to this exciting role as the QMS Sub System Lead – Training we are looking to identify the following on your profile and past history:
• A Degree or higher level in a technical or scientific discipline (e.g., Biomedical Engineering / Quality Assurance / Quality Management).
• Proven experience in quality management systems within a regulated industry, with extensive expertise supporting QMS remediation projects, audits, or inspections related to training.
• Strong knowledge of medical device regulatory requirements, including FDA 21 CFR 820 and ISO 13485.
• Demonstrated ability to lead cross-functional teams and manage complex remediation activities across multiple sites.
WHAT’S IN IT FOR YOU?
Joining our client offers the opportunity to work at the forefront of medical device quality compliance, supporting impactful remediation projects that shape the future of patient safety. You will gain exposure to global regulatory standards, develop advanced leadership skills, and contribute to a culture of excellence in a dynamic environment.
Key Words: QMS / Training / Remediation / Regulatory Compliance / CAPA / ISO 13485 / FDA 21 CFR 820 / Continuous Improvement / Medical Devices / Quality Management Systems
"Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career".
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
