Quality Engineer supporting ICU Medical Hardware and Consumable development. Ensuring compliance with quality system requirements and supporting design projects and CAPA investigations.
Responsibilities
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
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