Quality Systems Specialist-1.
Core
Independent quality representative supporting regulated IT projects by reviewing validation and lifecycle documentation, assessing compliance risks, and ensuring technology solutions meet quality and regulatory requirements.
Role type
Quality Systems Specialist (Regulated IT)
Builds
Compliant IT systems and processes for global stakeholders
Domain
Healthcare technology / Regulated IT / Medical Devices
Required skills
Validation lifecycle methodologies, Risk-based validation principles, Reviewing validation deliverables, System lifecycle record assessment, Regulatory requirement alignment, CAPA investigations, Audit readiness support, Supplier quality initiatives
Preferred skills
Medical device/pharmaceutical industry experience, ISO 13485 knowledge, FDA 21 CFR Part 11 knowledge, EU Annex 11 knowledge, Global virtual team collaboration, Project management
Technologies
Cloud solutions, Data platforms, Automation, Emerging digital initiatives
Responsibilities
Review and assess validation deliverables, testing documentation, risk assessments, and system lifecycle records; Provide quality and validation guidance to project teams; Evaluate project documentation for alignment with quality processes and regulatory requirements; Partner with global stakeholders to support compliant IT system implementation; Assess requirements and testing evidence to verify deployment readiness; Support audit readiness, CAPA investigations, and regulatory assessments; Contribute to continuous improvement initiatives for quality and compliance.
Seniority
Mid-level, hands-on IC