The Opportunity

This position works out of our Minnetonka, MN location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As the Quality Engineer I , you will assure new or modified products conform to requirements and establish compliance with the quality system. You are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. You will support new product development projects as well as support sustainability of commercially released product. You may also support manufacturing processes to meet daily production schedules while enhancing productivity and product quality. What You’ll Work On 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 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 specifications Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing) Lead the investigation, resolution and prevention of product and process non-conformances Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member) Lead in the completion and maintenance of risk analysis Work with design engineering in the completion of product verification and validation Work with microbiology 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 Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Required Qualifications Bachelor’s degree in engineering or Technical Field or an equivalent combination of education and work experience 0-2 years Engineering experience Ability to work in a highly matrixed and geographically diverse business environment Ability to work within a team and as an individual contributor in a fast-paced, changing environment Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization Multitasks, prioritizes, and meets deadlines in timely manner Strong organizational and follow-up skills, as well as attention to detail Preferred Qualifications Prior medical device experience preferred Experience working in a broader enterprise/cross-division business unit model preferred CAPA owner or a key cross-functional team member leading a CAPA project Use of quality tools/methodologies. Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971 Risk management, post market surveillance, and manufacturing analysis