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 114,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Working at Abbott At 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. Free medical coverage for employees* via the Health Investment Plan (HIP) PPO An excellent retirement savings plan with high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program and FreeU 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. The Opportunity We are seeking a Senior Quality Engineer to join our EP team at our St. Paul, MN location. 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. The individual in this position will assure new or modified products conform to requirements and establish compliance with the quality system. This position is 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. This position will support new product development projects as well as support sustainability of commercially released proact. This position will support manufacturing processes to meet daily production schedules while enhancing productivity and product quality. What You’ll Work On Provide guidance to other engineers and technical mentorship to engineers, technicians, and inspectors Be innovative, resourceful, and work with minimal direction Work effectively with cross-functional teams Lead on-time completion of new product development projects deliverables Manage projects which include new production equipment, process improvements and cost reductions while supporting new product introductions Create and ensure on-time execution of Quality Plans for internal development Accountable for Verification and Validation planning and execution, including active cross-functional root-cause analysis investigation and resolution activities Lead Risk Management activities, including analyzing field data to support new product development, and supporting Failure Mode Effects Analysis Support test and inspection method development, and lead method validation activities Support manufacturing process development and qualification for new product commercialization and product changes Support internal and external audit responses and on-time product re-certifications Support and ensure the establishment of objective, measurable, discrete, and verifiable customer and product requirements Complete Document Change Request Reviews in a timely and objective manner Participates in Corrective Action/Preventive Action (CAPA) process including the investigation of failures or deviations, as required. Develop and lead other team members Other Duties: Additional duties may be identified by functional management based on the current project/business objectives. Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements Required Qualifications Bachelor’s degree in Engineering or related scientific discipline 5-8 years of related work experience (3-6 years with relevant Master’s degree) Previous Quality Engineering experience and demonstrated use of Quality tools/methodologies Solid verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization Excellent organizational, problem solving, and team leadership skills 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 Ability to leverage and/or engage others to accomplish projects Multitasks, prioritizes and meets deadlines in timely manner Strong organizational and follow-up skills, as well as attention to detail Preferred Qualifications Advanced degree in a technical field Medical device experience, specifically with medical capital equipment manufacturing Experience working in a broader enterprise/cross-division business unit model Prior experience working with any or all of the following: ISO 13485 Medical Devices – Quality Management System 21 CFR Part 820 FDA Quality System Regulations ISO 14971 Medical Devices – Application of Risk Management EUMDR MDSAP Good Manufacturing Practices And Good Documentation Practices Apply Now * Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year. Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal. The base pay for this position is $72,700.00 – $145,300.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Operations Quality DIVISION: EP Electrophysiology LOCATION: United States > Minnesota > St. Paul > Tech Center : One St Jude Medical Drive ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT 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. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. Follow Us: Facebook LinkedIn YouTube Twitter