Sr. Quality Assurance Engineer; ISO

Essential Functions

• Ensure compliance with applicable regulatory standards, including FDA 21 CFR Part 820, ISO 13485, MDSAP, and EU MDR.
• Lead and support CAPA investigations, non‑conformance management, and root cause analysis using tools such as 8D, Fishbone, and 5 Whys.
• Own and continuously improve elements of the Quality Management System (QMS), including document control, internal audits, supplier quality, and change control.
• Collaborate cross‑functionally with R&D, Manufacturing, and Regulatory Affairs to support design control, risk management (ISO 14971), and product development lifecycle activities.
• Lead internal and supplier audits, and support external audits and inspections (e.g., FDA, Notified Bodies).
• Participate in validation activities (IQ/OQ/PQ) for processes, equipment, and software used in manufacturing and quality operations.
• Develop, monitor, and analyze quality metrics to identify trends, drive continuous improvement, and ensure effectiveness of corrective actions.
• Provide quality engineering support to Quality Control, including guidance on inspection methods, metrology, and measurement system capability.
• Conduct and document investigations of NCRs, complaints, and deviations, providing effective and sustainable corrective and preventive actions based on engineering analysis.
• Lead and mentor junior engineers, fostering technical growth and reinforcing a culture of quality and compliance.
• Integrate ISO 14971 risk management and IEC 62366 usability engineering activities within Glidewell/Prismatik processes.
• Ensure organizational compliance with the QMS through ongoing training, education, and internal communication.
• Collaborate with Manufacturing and Engineering to coordinate pilot production, process validations, and risk analyses for new products and processes.
• Ensure calibration and preventive maintenance systems meet compliance and operational requirements.
• Identify and implement process optimizations using Lean and Six Sigma methodologies to improve manufacturability, reduce risk, and enhance efficiency.
• Identify opportunities for design or re‑design of equipment, tools, and fixtures to improve manufacturing processes and product quality.
• Perform other related duties and special projects as assigned by management.

• Bachelor’s degree in Engineering, Science, or a related technical field.
• Minimum of 5 years of experience in Quality Assurance or Quality Engineering within the medical device industry, or equivalent education and experience demonstrating comparable skills and knowledge.
• Strong working knowledge of FDA regulations, ISO 13485, and other applicable international quality standards.
• Hands‑on experience with risk management (ISO 14971), design controls, and validation methodologies.
• Proven analytical, problem‑solving, and communication skills.
• Proficiency in quality and statistical analysis tools such as Minitab or equivalent software.
• Demonstrated project management experience.
• Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Six Sigma certification, preferred.
• Experience with combination products or Class I/II medical devices, preferred.
• Familiarity with EU MDR and UDI regulatory requirements, preferred.

Pay range: $85,000.00 - $/yr. Exact compensation may vary based on skills and experience.

This role is fully onsite at our Irvine, CA campus. Remote or hybrid arrangements are not available.