Abbott Senior Quality Professional – Quality Engineer in Lake Forest, Illinois
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.
This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support for new product development, manufacturing, and/or system/services support to drive continuous improvement and a robust quality management system.
Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements. Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements. Lead, coach, and mentor personnel at manufacturing sites with process expertise. Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Design and conduct experiments for process optimization and/or improvement. Appropriately document experiment plans and results, including protocol writing and reports. Lead process control and monitoring of CTQ parameters and specification. Lead and implement various product and process improvement methodologies (eg. Six Sigma and Lean Manufacturing). Lead the investigation, resolution and prevention of product and process nonconformances. Participate in or lead teams in supporting quality disciplines, decisions, and practices (eg. represent the Quality function as a Core Team Member). Lead in the completion, maintenance, and application of risk analysis. Work with design engineering in the completion of product verification and validation. Work with microbiology functions to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities.
Support all company initiatives as identified by management and in support of Quality Management System. , environmental management systems, and other regulatory requirements. Comply with U.S. FDA regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments. Maintain positive and cooperative communications and collaborations with all levels of employees, customers, contractor, and suppliers.
Apprenticeship or Bachelor’s degree in Life Science; Engineering; or closely related discipline is required OR relevant combination of education or experience.
At least 5 years work experience in Quality or related field experience; Less experience may be appropriate with advanced degree. Preferred experience in the Healthcare industry. Has a history of completing successful projects and driving positive compliance outcomes.
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 firstname.lastname@example.org