Quality Engineer II, Validation & Sustaining
ICU Medical · Salt Lake City, Utah, US
Position Summary This role is critical to ensuring that all processes, equipment, and systems involved in the manufacturing and development of ICU Products m...
Job description
Position Summary This role is critical to ensuring that all processes, equipment, and systems involved in the manufacturing and development of ICU Products meet the highest standards of quality and regulatory compliance. The Quality Engineer II, Sustaining will work closely with cross-functional teams, including R&D, Advanced Manufacturing Engineering, Manufacturing, and Quality Assurance, to validate equipment, processes, and software used in production. Essential Duties & Responsibilities: - Demonstrate an understanding and functional impact of changes to critical process in the manufacturing and testing of ICU products. - Develop and execute validation protocols (IQ/OQ/PQ) for manufacturing equipment, processes, and software systems. - Conduct risk assessments to identify critical quality attributes (CQAs) and critical process parameters (CPPs) for validation. - Create and review Quality Control Plans and process FMEA’s, - Ensure validation documentation is accurate, complete, and in accordance with regulatory and quality system requirements. - Maintain validation master plans, protocols, and reports as part of the company’s quality system documentation. - Improve the Quality Ma...