Quality Engineer # JN -062021-65035
Des Plaines, Illinois
Posted on: June 4, 2021
Industry: Database Administrator / Engineers
Job Number: JN -062021-65035
Title: Quality Engineer
Location: Des Plaines, IL
Duration: 12 months contract
- Responsible for supporting in vitro diagnostics assay research and development teams through the design and development process, including support of assay submissions as required. Additionally, the candidate will provide support for other design and compliance projects within the division.
- The candidate must provide solutions to a wide range of difficult problems while ensuring that those solutions are compliant, innovative, thorough, practical, and consistent with organizational objectives.
- Lead projects with cross-functional or broader scope or represent the team on cross-functional project teams; they must interact effectively with employees, managers, and cross-functional peers.
- They must be able to communicate confidently and effectively with management, peers, and key stakeholders.
- 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 formulate appropriate reasons and justifications for changes, including assessment 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 the application of IVDR standards to the design process is a plus.
- Maintains and ensures compliance to the quality system appropriate 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.
- Bachelor's 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 an advanced degree.
- Preferred experience in the Healthcare industry; preferred experience with assay development or assay support.
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