Quality Systems Specialist – Regulated IT

About the role

As a Quality Systems Specialist you will act as an independent quality representative for regulated IT projects, ensuring that technology solutions meet quality and regulatory standards. You will work in a global virtual environment, supporting a diverse portfolio of cloud, data, and automation initiatives.

Key responsibilities

• Review and assess validation deliverables, testing documentation, risk assessments, and system lifecycle records for regulated IT solutions.
• Provide quality and validation guidance to project teams throughout planning, execution, and implementation.
• Evaluate project documentation for alignment with quality processes, regulatory requirements, and internal standards.
• Support audit readiness, CAPA investigations, supplier quality initiatives, and regulatory assessments.
• Collaborate with global stakeholders to ensure compliant IT system implementation and continuous improvement.

Required profile

• Bachelor's degree and at least 2 years of experience in quality, compliance, validation, or regulated environments such as medical devices, pharmaceuticals, or life sciences.
• Experience reviewing, executing, or approving validation deliverables for regulated systems.
• Advanced English proficiency for effective collaboration with global teams.

Required skills

• Knowledge of validation lifecycle methodologies and risk‑based validation principles.
• Familiarity with ISO 13485, FDA 21 CFR Part 11, and EU Annex 11 regulations.