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.

Audit Planning & Execution

• 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 donorprocessing records, traceability, chain of custody, adverse reaction reporting, and tissue handling controls, as applicable.

 Corrective & Preventive Actions (CAPA)

• 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.

Supplier Quality Oversight

• 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.

 Inspection & Assessment Readiness

• 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.

 Quality System Improvement

• 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.

 Training & Mentorship

• Provide training and guidance to internal teams on AATB standards, audit expectations, and inspection readiness.
• Mentor junior auditors or quality team members, as applicable. 

Skill, Knowledge, and Abilities

• In-depth knowledge of AATB Standards, FDA tissue regulations, and Quality System Regulations.
• Strong understanding of donorprocessing, traceability, chain of custody, and tissue safety controls.
• Proven ability to lead audits and manage CAPAs through closure.
• Excellent audit writing, documentation, and regulatory communication skills.
• Ability to balance compliance rigor with operational practicality in a regulated manufacturing environment

Education and Experience Required

• Bachelor’s degree in Life Sciences, Biology, Biomedical Engineering, Quality, Regulatory Affairs, or a related scientific or technical field.
• 5+ years of quality auditing experience in a regulated life sciences environment, such as medical devices, human tissue, biologics, or biotechnology.
• Demonstrated experience auditing against FDA 21 CFR Part 1271, FDA 21 CFR Part 820, and ISO 13485 requirements.
• Hands-on experience planning and conducting internal audits and supporting external regulatory or third-party audits.
• Experience initiating, documenting, and managing Corrective and Preventive Actions (CAPA) through verification of effectiveness and closure.
• Working knowledge of Quality Management Systems (QMS), document control, change management, and inspection readiness practices.
• Strong written and verbal communication skills, including audit reporting and regulatory correspondence.

Education and Experience Preferred 

• Master’s degree in Life Sciences, Quality, Regulatory Affairs, Engineering, or a related discipline.
• 7–10+ years of progressive quality auditing experience in medical device, human tissue, or biologics organizations.
• Direct experience supporting or leading audits involving AATB Standards and AATB accreditation or reaccreditation cycles.
• ISO 13485 Lead Auditor certification or equivalent professional auditor certification.
• Formal AATB auditor training or experience working directly with AATB assessors.
• Experience conducting supplier, contract manufacturing organizations, and service provider audits.
• Prior participation as a key contributor during FDA inspections, ISO certification audits, or accreditation assessments.
• Experience mentoring or training junior auditors or quality professionals

The pay range for this position is $100,000 to $125,000 per year. This range reflects the base salary for this role in California. Actual compensation will be determined based on skills, experience, qualifications, and location within the state.

Induce Biologics is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or other protected characteristics.

Induce Biologics participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the United States.