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. Responsibilities 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. Quality Management System (QMS) 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. Validation and Qualification 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. Risk Management 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. CAPA & Deviation Management 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. Product & Process Improvement 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. Supplier Quality 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. Regulatory Compliance & Accreditation 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. Required Education and Experience 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. Background and Skill Set 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. What We Will Train 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 #J-18808-Ljbffr