Quality Engineer II: Validation & Sustaining Expert

ICU Medical; Salt Lake City (UT); On-site; USD 75,000 - 110,000; Full time

Job summary

ICU Medical is seeking a Quality Engineer II, Sustaining to ensure that ICU products meet quality and regulatory requirements. You will validate equipment, processes, and software, working with R&D, manufacturing, and QA teams to uphold FDA and ISO standards.

Role emphasizes risk assessment, documentation, and continuous improvement within the Quality Management System, including audits and cross-functional collaboration.

Qualifications

• Bachelor’s degree in STEM from an accredited college or university.
• 2-4 years’ experience working in a regulated manufacturing or pharmaceutical/healthcare environment.
• Proficiency with validation (IQ/OQ/PQ) and risk management.
• Strong knowledge of FDA 21 CFR Part 820, ISO 14971, ISO 13485.
• Proficiency in Minitab and statistical analysis software.

Responsibilities

• Demonstrate understanding of changes to critical processes in manufacturing and testing of ICU products.
• Develop and execute IQ/OQ/PQ validation protocols for manufacturing equipment, processes, and software.
• Conduct risk assessments to identify CQAs and CPPs for validation.
• Create and review Quality Control Plans and process FMEA’s.
• Ensure validation documentation is accurate and compliant with regulatory requirements.
• Maintain validation master plans, protocols, and reports in QMS.

Skills

Agile PLM / Oracle

GD&T concepts

Minitab

Microsoft Office

Cross-functional collaboration

Detail-oriented

Education

Bachelor’s degree in STEM

Tools

Statistical analysis software

Job description

ICU Medical is seeking a Quality Engineer II, Sustaining to ensure that ICU products meet quality and regulatory requirements. You will validate equipment, processes, and software, working with R&D, manufacturing, and QA teams to uphold FDA and ISO standards.

Role emphasizes risk assessment, documentation, and continuous improvement within the Quality Management System, including audits and cross-functional collaboration.