Senior Quality Engineer, Design

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, global complaints, manufacturing quality data, etc. Monitor product data to identify statistically significant trends and risks.
• Ensure compliance, alignment and consistency with ICU Medical’s quality system.
• Prepare, support and ensure the readiness for any potential internal and / or external audits and inspections.

Knowledge & Skills

Minimum Qualifications, Education & Experience

Seniority level

Seniority level

Mid-Senior level

Employment type

Employment type

Full-time

Job function

Job function

Engineering and Information Technology

Industries

Medical Equipment Manufacturing

Referrals increase your chances of interviewing at ICU Medical by 2x

Sign in to set job alerts for “Quality Engineer” roles.

Tijuana, Baja California, Mexico 8 hours ago

Tijuana, Baja California, Mexico 1 month ago

Tijuana, Baja California, Mexico 1 month ago

Tijuana, Baja California, Mexico 1 month ago

Tijuana, Baja California, Mexico 22 hours ago

Software Engineer (Python / Linux / Packaging)

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr