Design Quality Engineer II – Medical Devices

ICU Medical Inc; San Clemente (CA); On-site; USD 85,000 - 120,000; Full time

Job summary

ICU Medical Inc. in California seeks a Quality Engineer to provide quality support for consumables development, CAPA investigations, and post-market risk assessments, ensuring compliance with ISO 13485, ISO 14971 and 21 CFR 820.

You will work with cross-functional teams and participate in design reviews to assure product quality. The role emphasizes regulatory compliance, risk management, and continuous improvement, with the opportunity to contribute across design transfers, investigations, and

Qualifications

• Bachelor's degree in engineering or related field.
• Minimum of two years of experience in R&D and/or Quality.
• ASQ CQE certification preferred or ability to obtain within one year.

Responsibilities

• Effectively utilize quality tools and processes to assure product quality.
• Assures conformance with regulations of the FDA and other international regulatory agencies.
• Ensure all quality attributes for design changes are met.
• Participate in design reviews, test readiness reviews, cross functional teams, risk assessments, design transfers, etc.
• Ensure that potential product and process risks are evaluated, prioritized, and mitigated to continuously improve product quality.
• Support any potential internal and/or external audits and inspections.
• Effectively interact with cross-functional team members.
• Provide quality support for on-market product issues. Bring issues to closure and escalating to management for support as necessary.
• Work special projects as assigned

Skills

Quality systems

Risk management

CAPA

Design controls

Regulatory compliance

Medical standards

ISO 13485

ISO 14971

Education

Bachelor's degree in engineering

Job description

ICU Medical Inc. in California seeks a Quality Engineer to provide quality support for consumables development, CAPA investigations, and post-market risk assessments, ensuring compliance with ISO 13485, ISO 14971 and 21 CFR 820.

You will work with cross-functional teams and participate in design reviews to assure product quality. The role emphasizes regulatory compliance, risk management, and continuous improvement, with the opportunity to contribute across design transfers, investigations, and