QA Engineer - Medical Devices, ISO 13485

Prismatik; Irvine (CA); On-site; USD 70,000 - 100,000; Full time

Job summary

Prismatik in Irvine, CA is seeking a Quality Assurance Engineer to integrate quality into every stage of medical device development and manufacturing. You will own quality engineering, risk management, CAPA, validation, and QMS activities, collaborating across functions to ensure safety, performance, and regulatory compliance.

You will drive investigations, root cause analyses, design verification, and continuous improvement across processes and products, with an onsite role that emphasizes high

Qualifications

• Minimum three (3) years of experience in quality engineering and risk management.
• Knowledge of FDA regulations, ISO 13485, and international quality standards.
• Familiarity with ISO 14971 risk management and design controls.
• Experience with QC tools and root-cause analysis advisable.

Responsibilities

• Lead quality engineering activities to drive strong engineering knowledge.
• Develop QA programs to ensure products meet requirements.
• Investigate NCRs and complaints; implement CAPA actions.
• Support design verification testing and risk analyses/FMEA.
• Collaborate on calibration, validation, and manufacturing process improvements.
• Participate in training on ISO 14971 and quality tools.

Skills

Analytical skills

Problem-solving

Communication skills

Education

Bachelor’s degree in Science/Engineering

Advanced degree preferred

CQE/CQA certification or Six Sigma

Tools

Minitab

Job description

Prismatik in Irvine, CA is seeking a Quality Assurance Engineer to integrate quality into every stage of medical device development and manufacturing. You will own quality engineering, risk management, CAPA, validation, and QMS activities, collaborating across functions to ensure safety, performance, and regulatory compliance.

You will drive investigations, root cause analyses, design verification, and continuous improvement across processes and products, with an onsite role that emphasizes high