Engineer II, Design Quality

ICU Medical • San Clemente, CA

4d

About The Position

Position Summary Provide quality support for ICU Medical Hardware and Consumable development. The Quality Engineer will support activities such as CAPA investigations, 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

Requirements

• 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
• 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 2 - 4 years of experience in R D and/or Quality is required.

Nice To Haves

• ASQ CQE certification preferred or ability to obtain within one year.

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

Benefits

• ICU Medical provides a comprehensive total rewards package that includes:
• Competitive financial benefits, including a generous 401(k) match and (for eligible roles) our Annual Incentive Plan
• A wide range of benefit options at affordable rates
• Additional perks to assist employees with their work-life effectiveness, such as Paid Time Off, Company Holidays, and Tuition Reimbursement
• Additional information on health and welfare benefit offerings can be found at https://www.icumed.com/about-us/careers/investing-in-your-future/

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees