Senior Design Quality Engineer (hybrid - Lake Forest, IL)

ICU Medical • Lake Forest, CA

1d • Hybrid

About The Position

Provide quality support for ICU Medical Hardware and development. 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 to ensure products are developed/manufactured utilizing appropriate processes to design the highest level of quality into products as they are developed.

Requirements

• Must be at least 18 years of age
• Bachelor’s degree in engineering (Electrical, Mechanical, Biomedical, Software) or related field from an accredited college or university is required.
• Minimum of seven years of experience in R&D or Quality is required

Nice To Haves

• ASQ CQE or CSQE certification is desirable.

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 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.
• Work special projects as assigned

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior