Quality Engineer II: Design Quality & Compliance

Regulatory Jobs; San Clemente (CA); On-site; USD 71,000 - 102,000; Full time

Job summary

ICU Medical is seeking a Quality Engineer in California to support consumables development. You will participate in CAPA investigations, post‑market risk assessments, and design projects to ensure compliance with quality systems and regulations.

Work with cross‑functional teams to perform risk analyses, design verifications, and support audits. You will address on‑market issues and drive improvements to sustain product quality and regulatory compliance.

Qualifications

• Bachelor's degree in engineering (Electrical, Mechanical or Biomedical) required.
• Minimum of two years' experience in R&D and/or Quality.
• ASQ CQE certification preferred or obtainable within one year.

Responsibilities

• Lead CAPA investigations and post-market risk assessments.
• Support design projects and ensure compliance with ISO 13485, ISO 14971 and CFR 820.
• Assist with internal and external audits and inspections.
• Collaborate across cross-functional teams to improve product quality.
• Address on-market product issues and ensure timely resolution.
• Participate in design reviews and risk assessments.

Skills

Risk management

Quality systems

Regulatory knowledge

Education

Bachelor's degree in Engineering

Tools

ASQ CQE

Job description

ICU Medical is seeking a Quality Engineer in California to support consumables development. You will participate in CAPA investigations, post‑market risk assessments, and design projects to ensure compliance with quality systems and regulations.

Work with cross‑functional teams to perform risk analyses, design verifications, and support audits. You will address on‑market issues and drive improvements to sustain product quality and regulatory compliance.