Sr. Quality Assurance Analyst

At Induce Biologics USA Inc., we are focused on developing and providing advanced technologies for bone regeneration. With a foundation based on science, clinical evidence, and clinical experience, our Natural Matrix Protein® (NMP®) products support healing across a wide range of spine, dental, and orthopedic procedures.

By joining Induce Biologics USA Inc., you’ll be part of a mission-driven team working with revolutionary technology that’s reshaping the future of bone regeneration and making a real difference in patients’ lives.

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.

• Plan, schedule, and conduct internal audits, supplier audits, and external audits in accordance with FDA, ISO, and AATB requirements.
• Lead audits covering quality systems, tissue recovery, processing, storage, labeling, distribution, manufacturing operations, and documentation controls.
• Develop audit plans, checklists, and reports aligned with FDA 21 CFR Parts 1271 and 820, ISO 13485, and AATB Standards.
• Serve as a lead auditor or subject matter expert during FDA inspections, ISO certification audits, and AATB accreditation assessments.
• Evaluate compliance with donor processing records, traceability, chain of custody, adverse reaction reporting, and tissue handling controls, as applicable.

• Initiate, document, and manage CAPAs resulting from internal audits, supplier audits, FDA inspections, ISO audits, and AATB assessments.
• Partner with functional owners to ensure root cause analysis is thorough, corrective actions are effective, and preventive measures are sustainable.
• Verify effectiveness of corrective actions and ensure timely closure in accordance with QMS.

• Conduct and support supplier qualification, re-qualification, and ongoing surveillance audits.
• Assess supplier and partner compliance with AATB Standards, FDA regulations, and contractual quality requirements.
• Collaborate with Supply Chain and Quality teams to address supplier nonconformances, monitoring, risk mitigation, and continuous improvement activities.

• Maintain continuous inspection and accreditation readiness for FDA, ISO, and AATB.
• Support mock AATB audits, readiness assessments, and gap analyses.
• Ensure audit records, responses, and supporting documentation are complete, accurate, and readily retrievable for inspections and accreditation reviews.
• Assist in preparation, coordination, and response activities related to AATB reaccreditation cycles.

• Identify trends and recurring issues across audit findings, complaints, deviations, and quality data.
• Recommend and support enhancements to SOPs, training programs, and quality system processes to maintain compliance with regulatory and AATB standards.
• Support updates to documentation governing tissue handling, traceability, adverse event reporting, and donor processing, as applicable.
• Provide training and guidance to internal teams on AATB standards, audit expectations, and inspection readiness.
• Mentor junior auditors or quality team members, as applicable.

• In-depth knowledge of AATB Standards, FDA tissue regulations, and Quality System Regulations.
• Strong understanding of donor processing, traceability, chain of custody, and tissue safety controls.
• Pr…