Quality Engineer II

Quality Engineer IIAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to:Career development with an international company where you can grow the career you dream of.An excellent retirement savings plan with high employer contributionTuition reimbursement, the student debt program and education benefit - an affordable and convenient path to getting a bachelor's degree.A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.This position works out of our Plymouth, 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 II, you'll have the chance to assure products, processes, and quality records conform to quality standards and establish compliance within Abbott's quality system. We need you to be responsible for maintaining a strong collaborative partnership with multi-functional teams. Help facilitate success by protecting patient safety and meeting business needs. You will be involved in nonconformance and complaint investigation management, including root cause problem solving and providing event information to our various business partners (e.g. Regulatory, Quality Engineering).What You'll Work OnFollows all regulations and standards for quality, Environmental, Health, Safety, and Energy (EHS&E) Global Policies, Abbott engineering standards, and other governance areas as applicable.Implements and maintains the effectiveness of the Quality System.Identifies areas of risk with respect to compliance to internal and external requirements.Completes Non-conformance, CAPA, and complaint investigations and offers multiple solutions to issues with clear advantages and disadvantages.Influences key partners to develop and maintain QA procedures, forms, and systems.Leads meetings and communications for QA system information, concerns, and updates.Help drive standard methodologies for data trending and tracking and identification of manufacturing related complaints in alignment with Abbott goals.Follows 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.Performs other related duties and responsibilities, on occasion, as assigned.Required QualificationsBachelor level degree in Engineering, Technical Field, or equivalent (advanced degree preferred)2-5 years technical experiencePrevious Quality assurance/engineering experience and use of Quality tools/methodologiesGood communication and interpersonal skillsAdvanced computer skills, including statistical/data analysis and report writing skillsAbility to work within a team and as an individual contributor in a dynamic, changing environment.Strong verbal and written communication skills with ability to effectively communicate at multiple levels in the organization.Multitasks, prioritizes and meets deadlines in timely manner.Excellent organizational and follow-up skills, as well as attention to detail.Preferred QualificationsDetailed knowledge of FDA, GMP, and ISO 13485ASQ CQT, CQE, CQA certificationSix Sigma root cause analysis/problem solving training and experienceThe base pay for this position is $60,000.00 – $120,000.00 In specific locations, the pay range may vary from the range posted.JOB FAMILY: Operations QualityDIVISION: EP ElectrophysiologyLOCATION: United States > Minnesota > Plymouth : 5050 Nathan Lane NADDITIONAL LOCATIONS:WORK SHIFT: StandardTRAVEL: NoMEDICAL SURVEILLANCE: Not ApplicableSIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.