Quality Engineer

Quality Engineer Carlsbad, CA 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. More About Isto About Isto Biologics Leadership Company news Duties and Responsibilities Serves as a key quality engineering resource responsible for the design, maintenance, and continuous improvement of the Quality Management System (QMS) in compliance with

FDA 21 CFR

Part 1271 and AATB accreditation standards. Leads validation and qualification activities (IQ, OQ, PQ) for equipment, processes, and methods; applies risk-based approaches to ensure the ongoing validated state of critical systems. Owns CAPA and deviation management activities end-to-end, from investigation and root cause analysis through corrective action implementation and effectiveness verification. Conducts risk management activities across the product and process lifecycle, integrating risk-based decision making into validation, change control, CAPA, and product development. Supports product and process development activities, supplier quality management, and internal/external audit programs to ensure sustained regulatory compliance and accreditation readiness. Collaborates cross-functionally with Operations, Engineering, Facilities, and Marketing to embed quality requirements throughout product and process lifecycles and drive a culture of continuous improvement. Essential Duties and Responsibilities Quality Management System (QMS) Supports the maintenance, implementation, and continuous improvement of the QMS in compliance with

FDA 21 CFR

Part 1271 and AATB accreditation standards. Authors/reviews controlled documents (SOPs, work instructions, forms, records) and supports document control, internal/external audits/inspections, and change control activities. Validation and Qualification Leads the 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. Applies risk-based approaches to determine validation scope, sampling strategies, and acceptance criteria. Maintains validation master plans and the ongoing validated state of critical equipment/processes through periodic review and requalification as required. Risk Management Conducts and supports risk management activities across the product/process lifecycle (hazard identification, risk assessment/control, and residual risk evaluation). Authors/maintains risk documentation (e.g., FMEAs, risk control records) and integrates outputs into CAPA, change control, validation, and product development decisions. CAPA & Deviation Management Owns CAPA activities from initiation through closure, including root cause analysis, corrective/preventive action development, implementation oversight, and effectiveness verification. Leads or supports deviation and nonconformance investigations; applies structured root cause analysis tools (e.g., fishbone, 5-Why, fault tree) to identify systemic causes and prevent recurrence. Ensures timely, audit-ready documentation/closure of records and monitors trends to drive proactive improvements. Product & Process Improvement Provides quality engineering support for product/process development (specifications, scale-up) and cross-functional projects to integrate quality requirements through commercialization. Supports process improvement by applying quality tools such as process capability analysis, SPC, and failure mode analysis. Supplier Quality Supports supplier qualification activities including quality agreement review, supplier audit participation, and approval documentation in accordance with 21 CFR Part 1271 and AATB requirements. Monitors supplier performance and interfaces on quality issues/changes through review of incoming non-conformances, supplier CAPAs, and periodic performance assessments. Regulatory Compliance & Accreditation Ensures operational and project activities remain compliant with

FDA 21 CFR

Part 1271 HCT/P regulations and applicable AATB accreditation standards. Supports inspection/accreditation readiness for FDA, AATB, and other regulatory or third-party audits, including assistance with responses to observations and findings. Maintains current knowledge of applicable regulations, guidance documents, and industry standards; communicates 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). Demonstrated hands-on experience with testing, validation, and qualification activities. Must have experience independently authoring, executing, and reviewing

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. Must have 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; strong candidates from adjacent regulated industries will be 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. Able to effectively engage cross-functionally. This person will work alongside Operations, Engineering, Facilities, and Marketing and needs to be able to clearly communicate quality requirements. Strong documentation discipline; able to 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

Pay:

$90,000-$100,000 Interested in applying? Apply Here