Sr. Quality Assurance Engineer (ISO 13485)

Prismatik; Irvine (CA); On-site; USD 99,000 - 120,000; Full time

Job summary

Prismatik in Irvine, CA seeks a Sr. QA Engineer to embed quality across medical device development and manufacturing. You will own CAPA, risk management, validation, and QMS activities, collaborating with R&D, Manufacturing and Regulatory Affairs to ensure safety, performance, and compliance.

You will lead audits, drive continuous improvement, and mentor junior engineers, ensuring process controls meet global standards and patient safety is prioritized.

Qualifications

• Bachelor’s degree in Engineering, Science, or related field.
• 5+ years in Quality Assurance/Engineering in medical devices.
• Strong knowledge of FDA, ISO 13485, and international standards.
• Experience with ISO 14971, design controls, and validation.
• Proven problem-solving and communication abilities.
• Experience with Minitab or similar stats tools.

Responsibilities

• Ensure compliance with regulatory standards (FDA, ISO 13485, EU MDR).
• Lead CAPA investigations and root cause analysis.
• Maintain and improve QMS elements like document control and audits.
• Collaborate across R&D, Manufacturing, Regulatory affairs.
• Support design controls, risk management, and validation activities.
• Lead internal/supplier audits and participate in external audits.
• Develop quality metrics and drive corrective actions.

Skills

Quality Assurance

Regulatory knowledge

Risk management

CAPA

Statistical analysis

Education

Bachelor's degree in Engineering/Science

Tools

Minitab

Job description

We're looking for a Sr. QA Engineer to help build quality into every stage of our medical device development and manufacturing. You'll have broad ownership across quality engineering, risk management, CAPA, validation, and our Quality Management System. Working closely with cross-functional teams, you'll solve complex quality challenges, support new products and processes, and help ensure what we build meets the highest standards for safety, performance, and compliance.

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.

Minimum Qualifications:

• 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: $99,000 - $120,000/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.