Senior Medical Device QA Engineer – Lead Quality & Compliance

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

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.