Abbott Senior Professional Quality - Design Assurance 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.
Quality Assurance supporting Abbott Molecular R&D (Research and Development).
Conduct quality-related activities to deliver consistent, high quality documents, services, products and processes. Ensure compliance with world wide regulatory expectations/requirements.
General : Provide solutions to a wide range of difficult problems. Ensures that solutions are compliant, innovative, thorough, practical and consistent with organizational objectives. May lead projects with cross-functional or broader scope. Interacts effectively with employees; manager; and cross-functional peers. May represent own team while on cross-functional project teams with other functional leaders. Communicates confidently and effectively with management; peers; and key stakeholders. Implements tactical solutions related to assignment. Able to contribute functional skills and expertise broadly.
Design Control : Guides and influences new product teams through design, validation, and regulatory compliance and assures robust product vs. customer requirements. Possesses thorough understanding of design control lifecycle, including design inputs, verification, validation, and commercialization.
Documentation & Change Control : Assesses the impact of a change on field performance and customer expectations world-wide. Understands and assesses the impact of a change on the safety and efficacy of a device. Able to formulate thorough reasons and justifications for changes, including assessment of critical parameters and other affected systems/products.
Quality System: Maintains and ensures compliance to the quality system that is appropriate for the unit specific medical device(s) designed or manufactured. Ensures compliance to and is able to demonstrate knowledge of site level policies and procedures.
Education: 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 advanced degree. Preferred experience in the Healthcare industry.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com