Abbott Senior Professional, Design Assurance – Companion Diagnostics in Des Plaines, Illinois
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Abbott Molecular is currently seeking an experienced design quality assurance professional to support innovative companion diagnostics products. The Senior Professional, Quality Assurance will help guide research and development teams through the design and development process, including support of assay submission. Additionally, the candidate will provide support for other design and compliance projects within the division, focusing on IVDR compliance and implementation.
General: The candidate must be able to provide solutions to a wide range of difficult problems, while ensuring that those solutions are compliant, innovative, thorough, practical and consistent with organizational objectives. They may lead projects with cross-functional or broader scope, or may represent the team 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.
Design Control: 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, 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 application of IVDR standards to the design process a plus.
Quality System: The candidate will demonstrate ability to maintain and ensure compliance to the quality system and to site level policies and procedures.
Education and Experience: Bachelor's degree in Life Science, Engineering, or closely related discipline. At least 7 years work experience in Quality, Development or other related discipline (diagnostic quality, technical area, etc.); Less experience may be appropriate with advanced degree. Preferred experience in the Healthcare industry; preferred experience with assay development or assay support.
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