Engineer III, Design Quality
ICU Medical
full-time
Posted on:
Location Type: Hybrid
Location: San Clemente • California • United States
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Salary
💰 $90,000 - $129,000 per year
About the role
- Provide quality support for ICU Medical Hardware and Consumable development.
- Support activities such as CAPA investigations, design projects, and ensure compliance with ICU Medical quality system requirements.
- Effectively utilize quality tools and processes such as product and process controls, risk analysis/management tools, validation, design verification, investigations, CAPA data, etc.
- Assures conformance with regulations of the FDA and other international regulatory agencies.
- Provide compliance guidance concerning development, application, and maintenance of quality standards as related to product development within the quality system.
- Participate in design reviews, test readiness reviews, cross functional teams, risk assessments, design transfers, etc.
- Maintain Design History Files (DHF) up to date as needed.
- Support any potential internal and/or external audits and inspections.
Requirements
- Must be at least 18 years of age
- Bachelor’s degree in engineering (Electrical, Mechanical, Biomedical) or related field in engineering from an accredited college or university is required.
- Minimum of 4 years of experience in R&D and/or Quality is required.
- ASQ CQE certification preferred or ability to obtain within one year.
Benefits
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
quality supportCAPA investigationsdesign projectsproduct and process controlsrisk analysisvalidationdesign verificationinvestigationsdesign transfersDesign History Files
Certifications
ASQ CQE