Sr. Quality Assurance Analyst

The Sr. Quality Assurance Analyst is responsible for planning, conducting, and leading internal, supplier, and external audits to ensure compliance with applicable regulatory and quality system requirements, including FDA 21 CFR Part 1271, FDA 21 CFR Part 820, and ISO 13485 and Association for Advancing Tissue and Biologics (AATB) Standards. This role plays a critical part in maintaining inspection readiness, driving corrective and preventive actions (CAPA), and strengthening the effectiveness of the Quality Management System (QMS) across the organization and suppliers. The Sr. Quality Assurance Analyst partners cross-functionally with Quality, Manufacturing, Operations, Regulatory, and Supply Chain teams to identify risks, ensure timely remediation of audit findings, and support successful FDA inspections, ISO audits, and AATB accreditation assessments.