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. **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. + Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. + An excellent retirement savings plan with high employer contribution + Tuition reimbursement, the Freedom 2 Save (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) 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** This position works out of our Plymouth, MN location in the EP 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 a Staff Quality Engineer, you'll have the chance to be 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. + Lead, coach, and mentor non-exempt and lower-level exempt personnel. + 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 nonconformance’s. + 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 Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. + Performs other related duties and responsibilities, on occasion, as assigned. + Manages & monitor site NCMRs/CAPAs including reporting requirements, provide detailed updates and information in support of quality, also liaising with other Abbott sites to ensure compliance to quality system. + Perform or review manufacturing non-conformances reports, CAPA, failure investigations and audit findings to report manufacturing related issues that may impact quality and recommend courses of corrective action. + Prepare metrics for NCMRs / CAPA suppliers’ performance, analyze process data and trends and drives optimization and improvement. Perform and report line defects trend analysis. **Required Qualifications** + Bachelor’s Degree (± 16 years) in Engineering or Technical Field with an equivalent combination of education and work experience. + Minimum 8+ years’ experience + Demonstrated use of Quality tools/methodologies. + Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971. + Solid communication and interpersonal skills. + Strong 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 manner. + Advanced computer skills, including statistical/data analysis and report writing skills. + Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing). + Ability to work in a highly matrixed and geographically diverse business environment. + Ability to work within a team and as both a leader and 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. + Ability to maintain regular and predictable attendance. **Preferred Qualifications** + Demonstrated supervisory experience preferred. + ASQ CQE or other certifications preferred. + Experience working in a broader enterprise/cross-division business unit model preferred. + Prior medical device experience preferred. Apply Now (https://www.jobs.abbott/us/en) **Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:** www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx) 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 $97,300.00 – $194,700.00. In specific locations, the pay range may vary from the range posted. An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com