Des Plaines, Illinois, United States
Job type: contract
Job industry: Engineering
Quality EngineerPay Rate: $40.71/ HR8:30am-4:30pmCortech is seeking a Quality Engineer for our client in Des Plaines, IL.The Professional, Quality Assurance will be responsible for supporting assay or instrument research anddevelopment teams through the design and development process, including support of submissions asrequired. Additionally, the candidate will provide support for other design and compliance projectswithin the divisionJob Description:--The candidate must be able to provide solutions to a wide range of difficult problems, whileensuring that those solutions are compliant, innovative, thorough, practical and consistent withorganizational objectives. --They will serve as the QA team member on cross-functional project teams must be able to interact effectively with employees, manager, and cross-functional peers. --They must be able to communicate confidently and effectively with management, peers, and key stakeholders--The candidate maintains and ensures compliance to the quality system that isappropriate for the unit specific medical device(s) designed or manufactured. --They must be able to ensure compliance to, and is able to demonstrate, knowledge of site level policies and procedures--The candidate will guide and influence new product development teams through design, validation, and regulatory compliance and assure robust product vs. customer requirements.--They should be able to formulate appropriate reasons and justifications for changes, includingassessment of crucial parameters and other affected systems/products. --They should possess a thorough understanding of the design control lifecycle, including design inputs, verification, validation, and commercialization. Knowledge of application of IVDR standards to the design process a plus.Requirements: --Bachelors degree in Life Science, Engineering, or closely related discipline. --At least 5 years work experience in Quality or related field experience (diagnostic quality, technical area, etc)-- Less experience may be appropriate with advanced degree. Preferred experience in the Healthcare industry preferred experience with assay or instrument development or support.