Engineer III, Design Quality

RXinsider LTD.; Lake Forest (IL); On-site; USD 90,000 - 120,000; Full time

Job summary

RXinsider LTD. seeks a Quality Engineer to support ICU Medical Hardware and Consumable development, ensuring compliance with ISO 13485, ISO 14971, 21 CFR Part 820.

You will lead CAPA investigations, participate in design reviews and risk assessments, and work with cross-functional teams to mitigate product and process risks while preparing for audits.

Responsibilities

• Utilize quality tools and processes to assure product quality.
• Ensure conformance with FDA and international regulatory requirements.
• Provide guidance on development and maintenance of quality standards as related to product development within the quality system.
• Ensure that quality attributes for design changes are met.
• Participate in design reviews, test readiness reviews, cross-functional teams, risk assessments, design transfers.
• Evaluate, prioritize, and mitigate design and process risks to continuously improve product quality.
• Support internal and external audits and inspections.

Job description

Job Description

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.
• Provides compliance guidance concerning development, application, and maintenance of quality standards as related to product development within the quality system.
• 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.oops wait no; there was a mistake; The
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• Support any potential internal and/or external audits and inspections.
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