Job Details:
ICU Medical currently has an open position for a Quality Engineer located in Salt Lake City, Utah.
The Quality Engineer will write and conduct verification/validation protocols and reports for new or revised products and components. Write product performance specifications and assure that all product specifications define and test for clinically accepted standards as well as compliance to appropriate ISO standards. Provide Technical support to R&D, Marketing, Design Engineering and Project Management for new product activities including Design Controls and Risk Management. Actively participate on various project teams providing QE support at the depth commensurate with the project.
Candidate must have excellent analytical skills, technical writing capabilities and the knowledge of and application of statistical methods. Knowledge of medical device validation requirements is required, design control, FMEA/Hazard analysis, CAPA experience is required. Automated assembly and/or injection molding validation background are a plus. Must be Computer literate and able to use word processing, spreadsheet, and statistical analysis programs. Must be able to effectively manage multiple projects in a fast paced, cost- conscious environment. Good interpersonal skills and the ability to interact with all levels of the company, sometimes in an advisory role.
Must have excellent project management skills and be capable of handling multiple projects. Minimum 2 years’ experience in the Medical Device Industry. Bachelor’s degree in Engineering sciences or related scientific field required. CQE/CRE Certification desirable. Experience with the design and manufacture of IV Infusion medical devices a plus. Infrequent international travel required.
This is an EXCELLENT OPPORTUNITY for an eager, reliable individual to join our busy, successful team. Our requirements are high, but in return we offer competitive compensation, full array of outstanding benefits, and the advantages of a company exhibiting consistent annual growth...
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