Senior Quality Engineer

Sr. Quality EngineerAbbott 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 122,000 colleagues serve people in more than 160 countries.Working at AbbottAt 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 of which you dream.An excellent retirement savings plan with high employer contributionTuition 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 OpportunityThis position works out of our St. Paul, Minnesota location in the Vascular Division. This role is fully onsite role.Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease.The Senior Quality Engineer will be responsible for providing quality engineering support and leadership within product manufacturing, design transfer, and process/system/services in the manufacturing of Class II & III medical devices. In addition, they will provide daily quality engineering support to resolve production issues and maintaining process stability. Will support manufacturing line for any issues on manufacturing or production lines.What You'll DoIdentify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirementsLead the investigation, resolution and prevention of product and process nonconformances and CAPAsApply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issuesAssist in the development and execution of streamlined business systems which effectively identify and resolve or prevent quality issuesLead process control and monitoring of Critical To Quality (CTQ) parameters and specificationsLead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)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 in support of the Risk Management FilesWork with design engineering in the completion of product verification and validationWork with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activitiesMaintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.Required Experience:Bachelor's Degree in Engineering or Technical Field; advanced degree preferredMinimum 6+ years of related work experience or an equivalent combination of education and work experienceEngineering experience and demonstrated use of Quality tools/methodologiesDetailed knowledge of FDA, GMP, ISO 13485, and ISO 14971Preferred Experience :Solid communication and interpersonal skillsStrong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective mannerAdvanced computer skills, including statistical/data analysis and technical report writing skillsCertified Quality Engineer AccreditationThe base pay for this position is $78,000.00 – $156,000.00. In specific locations, the pay range may vary from the range posted. Abbott