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: Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. 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. The Opportunity This position works out of our Minnetonka, MN location in the Cardiac Rhythm Management division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. Quality Engineer I is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. 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 Assist 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 nonconformances 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. EDUCATION AND EXPERIENCE YOU’LL BRING Bachelors Degree Or an equivalent combination of education and work experience Entry level position in which 0-2 years of experience is typical to meet the skills and responsibilities of the position. Engineering experience (preferred) Knowledge of FDA Quality System Requirements and other applicable US Code of Federal Regulations for Devices. Knowledge of ISO 13485 standard. Knowledge of quality management techniques and application. Ability to clearly, concisely and accurately convey communications. Ability to form and develop interpersonal, professional relationships. Display socially and professionally appropriate behavior. Ability to work independently and in groups. Ability to work cross-functionally. Demonstrated initiative and problem-solving skills. Critical-thinking skills. Ability or aptitude to use various types of databases and other computer software. Strong organizational skills. Ability to prioritize. Ability to multitask. Ability or aptitude to provide solutions and contingency plans through the comprehensive review of alternatives. Ability to quickly gain knowledge, understanding or skills and is willing to learn. 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 $48,000.00 – $96,000.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Operations Quality DIVISION: CRM Cardiac Rhythm Management LOCATION: United States > Minnesota > Minnetonka : 14901 DeVeau Place ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Not specified 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