Sr. QA Engineer — Medical Devices ISO 13485, Onsite Irvine

PRISMATIK DENTALCRAFT, INC.; Irvine (CA); On-site; USD 99,000 - 120,000; Full time

Job summary

Prismatik Dentalcraft, Inc. in Irvine, CA is seeking a Senior QA Engineer to embed quality across medical device development and manufacturing.

You will own CAPA, risk management, QMS elements, and validation activities while collaborating with R&D, Manufacturing, and Regulatory Affairs to ensure safety, performance, and regulatory compliance. The role requires 5+ years in QA for medical devices, strong FDA/ISO knowledge, and leadership in quality engineering with a hands-on approach.

Qualifications

• Bachelor's degree in Engineering, Science, or a related technical field.
• Minimum of 5 years of experience in Quality Assurance/Quality Engineering within the medical device industry.
• 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.

Responsibilities

• Ensure compliance with 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 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 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.

Job description

Prismatik Dentalcraft, Inc. in Irvine, CA is seeking a Senior QA Engineer to embed quality across medical device development and manufacturing.

You will own CAPA, risk management, QMS elements, and validation activities while collaborating with R&D, Manufacturing, and Regulatory Affairs to ensure safety, performance, and regulatory compliance. The role requires 5+ years in QA for medical devices, strong FDA/ISO knowledge, and leadership in quality engineering with a hands-on approach.