IT Document and QMS Specialist

Role Overview This position focuses on supporting and maintaining the IT Quality Management System (QMS) and associated training programs to ensure compliance with applicable regulations, standards, and internal procedures. The IT Document and QMS Specialist partners closely with IT, Quality, and business stakeholders to ensure IT processes, systems, and personnel meet regulatory and organizational requirements. This role is critical for maintaining document control, training programs, and quality compliance across IT operations. Key Responsibilities - Develop, implement, and maintain IT QMS processes, procedures, and documentation while ensuring alignment with regulatory requirements such as FDA, ISO 13485, ISO 27001, and GxP standards - Manage controlled documents within the electronic QMS including document lifecycle activities such as authoring, review, approval, revision, and retirement - Support IT audits, inspections, and assessments by preparing documentation, responding to auditor questions, and tracking corrective actions - Create and administer the Training Matrix, IT training programs, and Learning Management System to ensure accuracy, compliance, and effectiveness for IT personnel and system users - Collaborate with IT, Quality, and business teams to ensure validation and qualification deliverables align with QMS requirements and track CAPAs, deviations, and change management activities Required Qualifications - Bachelor's degree in Information Technology, Computer Science, Quality, Life Sciences, or related field with equivalent professional experience - Minimum 3 years of experience in IT Quality, QMS, Compliance, and Training in a regulated environment - Hands-on experience with electronic QMS and Learning Management System platforms - Strong understanding of IT controls, system documentation, and both regulated and non-regulated environments - Experience supporting audits and inspections with excellent written and verbal communication skills Why Join Us Join UST and work with a leading IT services and consulting organization that values quality excellence and continuous improvement. This role offers the opportunity to impact IT quality management and training programs in a regulated environment with exposure to international standards and best practices.

- Bachelor's degree in IT, Computer Science, Quality, Life Sciences or related field - 3+ years IT Quality, QMS, Compliance, or Training experience in regulated environment - Electronic QMS and Learning Management System platform expertise - IT controls and system documentation knowledge - Audit and inspection support experience - Excellent written and verbal communication skills - Medical device, pharmaceutical, or biotech industry experience preferred - FDA QSR, ISO 13485, GxP, ISO 27001 knowledge preferred - System validation and qualification experience preferred - Risk-based thinking and continuous improvement mindset