Engineer II, Design Quality (Hybrid - San Clemente, CA)

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

Position Summary

Provide quality support for ICU Medical Consumables development. The Quality Engineer will support activities such as CAPA investigations, Post Market Risk Assessments, design projects, and will ensure compliance with ICU Medical quality system requirements and applicable regulations and standards, such as ISO 13485, ISO 14971, 21 CFR Part 820, and other applicable regulations and standards.

Essential Duties & Responsibilities

• Effectively utilize quality tools and processes such as product and process controls, risk analysis/management tools, validation, design verification, investigations, CAPA data, etc. 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 and for on-market product issues. Bring issues to closure and escalating to management for support as necessary.
• Work special projects as assigned

Knowledge & Skills

• Knowledge of Quality Management Systems and experience linking risk management to all elements of the Quality System (Design Controls, CAPA, Complaints, Document Control, etc.)
• Knowledge of medical device standards.
• Knowledge of medical device standards, including but not limited to: ISO 13485 and ISO 14971

Minimum Qualifications, Education & Experience

• Must be at least 18 years of age
• Bachelor's degree in engineering (Electrical, Mechanical, Biomedical) or related field from an accredited college or university is required.
• Minimum of two years of experience in R&D and/or Quality is required.
• ASQ CQE certification preferred or ability to obtain within one year.

Work Environment

This is largely a sedentary role.

This job operates in a professional office environment and routinely uses standard office equipment.

Typically requires travel less than 5-10% of the time