Direct message the job poster from ICU Medical
Human Resources Professional, SHRM-CP, HRBP
Position Summary
Provide quality support for ICU Medical Product and Development and design changes. The Sr. Quality Engineer will be responsible for development procedures and deliverables, ensuring their 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). The Sr. Quality Engineer will provide quality assurance support for product realization/manufacturing teams. Reporting to the Quality Manager, this individual will be the Quality Core Team Member for ensuring products are developed/manufactured utilizing appropriate processes to design the highest level of quality into products as they are developed.
- 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 and may assist in providing responses to the FDA and other regulatory agencies with respect to medical device compliance.
- Provides compliance guidance concerning development, application, and maintenance of quality standards as related to product development within the quality system.
- Work with cross-functional teams to coordinate product changes.
- Participate in design reviews, test readiness reviews, cross functional teams, risk assessments, design transfers, etc.
- Provide corporate quality support, guidance and direction for bringing on-market product issues to closure and escalating to senior management for support as necessary.
- Ensure that potential product and process risks are evaluated, prioritized, and mitigated to continuously improve product quality.
- Utilize a wide variety of data sources including product review, glo

📌 Senior Quality Engineer, Design (Tijuana)
🏢 ICU Medical
📍 Tijuana