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. **Senior Quality Engineer** for Structural Heart, this position is based in Caguas, Puerto Rico. Available to travel all territories. **About Abbott** 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 will have access to: + Career development with an international company where you can grow the career you dream of. + Health Insurance (starting on Day 1 of employment), Savings Plan (401K) with company match, Life insurance for you and your spouse/children, Short Term Disability, Long Term Disability, Education Assistance, Employee Assistance Program, Vacation, Sick, Personal Days. + 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 is based in **Caguas** , **Puerto Rico** for our **Structural Heart** Division. Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. As a Senior Quality Engineer, you will provide process/quality engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer by assisting in the identification and resolution of quality related issues. **What** **You’ll** **Do** + Responsible for compliance with applicable Corporate and Divisional Policies and procedures. + Identifies manufacturing process defects (scrap, nonconforming material, customer complaints), dispositions non conforming material, leads identification of primary root causes for complex investigations, identifies appropriate corrective and preventive actions without oversight, and trains others in effective CAPA methods. + Manages quality issues of moderate to high complexity with significant business impact with minimal to no oversight. + Responsible for ensuring prompt communication of these issues as they arise and keeping management informed of the investigation status throughout the investigation and resolution lifecycles. + Leads line support team (QC Supervisor, Mfg. Supervisor, Quality Engineer and Operations) to perform line situation triage and determine if non-conformance present can impact distributed product, determine initial bracketing and containment, and initiate stop ship and escalation process as required. + May be responsible for reporting of quality metrics. + May lead team in developing product quality plans, documents and systems by providing direction for setting product specifications, quality specifications, quality plans, risk analyses, and FMEAs. + Responsible for providing support during internal and external audits. + May be responsible for owning and maintaining product risk analyses and FMEAs. Mentors others in risk management process. + Proficiently utilizes process monitoring tools and Infinity QS to understand process shifts and aims to reduce process variation. Mentors and trains others in SPC tools and process controls. + Develops Quality Tools & Training Materials and trains others in use of prevalent tools and available training materials. + Can lead Product/Process improvement efforts (e.g). scrap, nonconforming product, customer complains) by systematically gathering quality metric data and by using appropriate analysis methods to enhance sustaining product design. + Leads or supports Divisional Product/Process improvement efforts by understanding current quality metric data to enhance sustaining product design, new product development, and compliance. + Runs complex problem-solving efforts with minimal oversight, and mentors’ others on best practices. + Implements complex changes through change management system and provides quality engineering impact assessment for changes implemented by other functional areas and/or sites. + Works towards reducing site non-conformance index year over year. + Writes protocols and reports with no oversight to support engineering studies and validations. Can develop complex test strategies, summarize statistical data, and mentor others in best practices. + Works with minimal to no oversight. **Required** **Qualifications** + Bachelor's in engineering. + Minimum 5 years of experience. Experience Details: + Relevant experience in Quality and/or Compliance, preferably in medical device industry. + Knowledge of applicable US & non-US applicable regulations. + Knowledge and proficiency in the application and principles of Quality Engineering. + Ability to effectively lead cross-functional teams in resolving Quality issues. + Excellent written, verbal and interpersonal communication skills. + Ability to evaluate complex process. + Ability to interact effectively with all levels of employees. + Advanced proficiency in English and Spanish. Speaking, listening, reading and writing. + Digital skills: Microsoft office. Apply now (https://www.jobs.abbott/) 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 $66,000.00 – $132,000.00. 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