Quality Assurance Specialist

The Quality Assurance Specialist engages in planned and systematic activities to ensure quality requirements and improvement standards are met within the Life Sciences and Clinical Diagnostics sector. This role involves analyzing processes to recommend revisions or create new protocols, policies, and systems while maintaining compliance with ISO 13485 and FDA Quality System Requirements. The position requires conducting internal audits, managing document control, and supporting regulatory inspections to uphold product quality and safety.