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Senior Engineer, Quality

ICU Medical · Salt Lake City, Utah, US

Position Summary The Senior Quality Engineer – Sustaining and Validation (Quality Operation) provides hands-on technical quality engineering support and dire...

Job description

Position Summary The Senior Quality Engineer – Sustaining and Validation (Quality Operation) provides hands-on technical quality engineering support and direction in quality assurance and quality control aspects of the SLC operation to facilitate an environment of compliance and meeting business objectives. Completes advanced validation projects with peer input and guidance from engineering and validation management. Work is highly independent. May assume a team lead role for the work group. The position requires good knowledge of the disciplines within a medical device QMS and knowledge and understanding of manufacturing, quality control processes and risk management. The incumbent will focus on verification and validations of products and processes and on the proper resolution of nonconformances at any point during the validation process. This position will advocate and lead the execution of initiatives & projects to enhance quality performance within the business and ensure compliance to applicable regulations and standards. The person in this role must have excellent communication and leadership skills, and the ability to plan, multi-task and manage time effectively to ensure a...