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.
2-6 years of experience in the medical device, IVD, or pharmaceutical industry, with increasing responsibility in quality assurance and CAPA systems.
Experience with Agile or an equivalent Product Lifecycle Management system is beneficial.
Technical Bachelor's degree or higher preferred.
Experience in medical device, pharmaceutical, life sciences, manufacturing, or another regulated industry would be advantageous.
Assist with data analysis and the development of key performance indicators, KPIs, for various functions.
Modify, maintain, and create procedures and processes as required.
Prepare and manage documentation and follow-up actions from site CAPA Review Board meetings.
Serve as a divisional point of contact for the CAPA process and provide input into global process improvements and training content.
Participate in internal and external quality audits, including supporting front-room and/or back-room audit workstreams.
Support audit and inspection preparation by communicating with functional areas and collecting relevant data to improve audit efficiency.
Administer the collection and organization of divisional Management Review materials.
