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.

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.

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