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

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