About the Role:
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.