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Quality Engineer

Company: Cypress HCM
Location: Santa Ana
Posted on: February 17, 2021

Job Description:

We have an exciting opportunity for a Quality Engineer position with one of the top medical device companies in the country. This position will provide risk management activities including planning, assessment, quantification, implementation of risk control measures, and effectiveness within an ISO regualted environment. Responsibilities:* Development, application, revision, and maintenance of documentation for design control and processing materials into partially finished or finished products, inspection and process development, qualification of equipment, validation of processes, including test method and some level of software validations. * Provides quality assurance support to the company Manage or assume functional responsibility for bigger projects or multiple smaller projects. * May supervise other Engineers, or manage other resources (external partners, contracts, budgets, etc) May have some type of Financial Responsibilities: cost center and capital purchases Demonstrate project ownership and accountability for project results * Develop working relationships outside of department, cross functionally. * Think strategically as it pertains to a given project. * Demonstrated effective negotiation skills and can work through obstacles effectively * Develop or assist in design verification activities (protocols and reports) * Develop and execute design validation activities (protocols and reports) * Develop and execute process validation protocols and reports for manufacturing, inspection, or test equipment * Develop and validate measurement method; software validation capability a plus. * Respond to internal CAPA and QA audit findings support developmental projects Qualifications * Bachelors degree within engineering or science required * ASQ Certified Quality Engineer or Six Sigma Black Belt preferred * Knowledge of quality assurance practices within the medical device industry, including FDA Quality System Requirements (QSR) and ISO 13485 DMAIC problem solving and analytical skills * 25% Travel

Keywords: Cypress HCM, Santa Ana , Quality Engineer, Engineering , Santa Ana, California

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