Experience working within Quality Assurance, Quality Systems, or a related regulated environment.
Working knowledge of Quality Management Systems, QMS.
Experience supporting CAPA processes, root cause analysis, effectiveness checks, and quality investigations.
Understanding of audit preparation and support activities, including internal audits, external audits, and/or regulatory inspections.
Ability to analyze data and support the development of quality metrics and KPIs.
Experience creating, maintaining, or improving procedures, processes, training materials, or quality documentation.
Experience in medical device, pharmaceutical, life sciences, manufacturing, or another regulated industry would be advantageous.
Technical Bachelor's degree or higher preferred.
Experience with Agile or an equivalent Product Lifecycle Management system is beneficial.
