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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 lifecycles 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 of applicable regulations, guidance documents, and industry standards; communicate relevant updates to Quality and Operations.

• 5+ years of quality engineering experience in a regulated industry (HCT/P, pharmaceutical, biotech, or medical device).
• Bachelor’s degree required in Engineering (biomedical, chemical, mechanical, or related discipline) or a life/biological science field (microbiology, biochemistry, bioengineering, or equivalent).
• Demonstrated hands‑on experience with testing, validation, and qualification activities; independent authoring, execution, and review of IQ, OQ, PQ protocols and reports.
• Experience leading deviation and nonconformance investigations, including problem definition, root cause analysis, development of corrective and preventive actions, and effectiveness verification.
• Familiarity with performing change control functions.
• Experience with risk management processes and documentation (e.g., FMEA, hazard analyses aligned with ISO 14971).
• Proven track record with CAPA ownership from initiation through root cause analysis, corrective action, and effectiveness verification.
• Experience supporting product development or process improvement activities from a technical and quality engineering perspective.
• Supplier quality and internal/external audit experience preferred.
• 21 CFR Part 1271 or AATB experience preferred; candidates from adjacent regulated industries considered.

• Strong critical thinking and analytical problem‑solving skills.
• Comfortable with analyzing data; able to apply statistical thinking to validation, process monitoring, and quality metrics.
• Solid understanding of QMS structure and how quality engineering functions connect and support one another.
• Effective cross‑functional engagement; collaborate with Operations, Engineering, Facilities, and Marketing, communicating quality requirements clearly.
• Strong documentation discipline; produce technically sound, audit‑ready documents independently.
• Proficiency with Microsoft Office Suite; experience working within a structured, document‑controlled quality system.

• HCT/P‑specific regulatory requirements (21 CFR Part 1271) and AATB accreditation standards, if not already familiar.
• Company‑specific QMS processes, SOPs, and quality system structure.
• Product and process knowledge specific to our operations.

Schedule: Full time, on‑site, occasional travel required