Quality Engineer

Isto Biologics is a growing, 100% biologics‑focused company committed to helping patients heal faster by providing a range of advanced solutions to surgeons of varying specialties. Isto is seeking a full‑time Quality Engineer for their Carlsbad, CA location.

• Design, maintain, and continuously improve the Quality Management System (QMS) in compliance with FDA 21 CFR Part 1271 and AATB accreditation standards.
• Lead validation and qualification activities (IQ, OQ, PQ) for equipment, processes, and methods; apply risk‑based approaches to maintain the validated state of critical systems.
• Own CAPA and deviation management activities end‑to‑end, from investigation and root cause analysis through corrective action implementation and effectiveness verification.
• Conduct risk management activities across the product and process lifecycle, integrating risk‑based decision‑making into validation, change control, CAPA, and product development.
• Support product and process development activities, supplier quality management, and internal/external audit programs to ensure sustained regulatory compliance and accreditation readiness.
• Collaborate cross‑functionally with Operations, Engineering, Facilities, and Marketing to embed quality requirements throughout product and process life cycles and drive a culture of continuous improvement.

• Support maintenance, implementation, and continuous improvement of the QMS in compliance with FDA 21 CFR Part 1271 and AATB accreditation standards.
• Author and review controlled documents; support document control, internal/external audits/inspections, and change control activities.

• Lead development, execution, and approval of validation/qualification protocols and summary reports for equipment, processes, cleaning, and methods (IQ/OQ/PQ), partnering with Operations/Engineering/Facilities to schedule and execute with minimal production disruption.
• Apply risk‑based approaches to determine validation scope, sampling strategies, and acceptance criteria.
• Maintain validation master plans and the ongoing validated state of critical equipment/processes through periodic review and requalification as required.

• Conduct and support risk management activities across the product/process lifecycle (hazard identification, risk assessment/control, and residual risk evaluation).
• Author and maintain risk documentation (e.g., FMEAs, risk control records) and integrate outputs into CAPA, change control, validation, and product development decisions.

• Own CAPA activities from initiation through closure, including root cause analysis, corrective/preventive action development, implementation oversight, and effectiveness verification.
• Lead or support deviation and nonconformance investigations; apply structured root cause analysis tools (e.g., fishbone, 5‑Why, fault tree) to identify systemic causes and prevent recurrence.
• Ensure timely, audit‑ready documentation/closure of records and monitor trends to drive proactive improvements.

• Provide quality engineering support for product/process development (specifications, scale‑up) and cross‑functional projects to integrate quality requirements through commercialization.
• Support process improvement by applying quality tools such as process capability analysis, SPC, and failure mode analysis.

• Support supplier qualification activities including quality agreement review, supplier audit participation, and approval documentation in accordance with 21 CFR Part 1271 and AATB requirements.
• Monitor supplier performance and interface on quality issues/changes through review of incoming non‑conformances, supplier CAPAs, and periodic performance assessments.

• Ensure operational and project activities remain compliant with FDA 21 CFR Part 1271 HCT/P regulations and applicable AATB accreditation standards.
• Support inspection/accreditation readiness for FDA, AATB, and other regulatory or third‑party audits, including assistance with responses to observations and findings.
• Maintain current knowledge…