Administrative Support – scheduling meetings, preparing reports, and maintaining audit and CAPA schedules.
Audit Support – prepare for internal and external quality audits by organizing documentation and ensuring compliance with relevant standards (ISO 9001 and ISO 27001) and HIPAA and GDPR regulations.
Process Support – Assist in implementing and monitoring quality processes and systems to ensure they meet organizational standards and objectives.
Training and Compliance - Manage internal employee training in the STARlearn (LITMOS) system, provide data on training completion rates, create training modules as needed, and ensure training is completed promptly.
Data Collection and Analysis – Gather and organize quality-related data to support internal audits, management reviews, and continual improvement efforts.
Continual Improvement – participate in projects aimed at improving the efficiency and effectiveness of the quality and information security management systems.
Requirements
5 -10 years of experience working with ISO 9001:2015 and ISO 27001:2022 standards, either as an internal or external auditor or Quality Assistant.
Certification with ASQ or Exemplar Global is a plus.
Self–starter – must be able to work with minimal supervision, pro-active, open to new concepts, and engage with others without prompting.
Attention to Detail – must be meticulous in work approach to ensure accurate record-keeping and quality control.
Organizational Skills – Must be able to manage multiple tasks, documents, and projects without reminders.