Senior Quality Engineer

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 115,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Senior Quality Engineer. This position will support the Structural Heart business and will be based in Caguas, Puerto Rico. On-site position. 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 will provide support to our Medical Devices / Structural Heart business. 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. 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 the Senior 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 degree in engineering. Minimum 5 years of experience. 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 in Spanish and English. Ability to evaluate complex process. Ability to interact effectively with all levels. Digital skills, Microsoft office Apply now 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 on Facebook at 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. JOB FAMILY: Operations Quality DIVISION: SH Structural Heart LOCATION: Puerto Rico > Caguas : West Industrial Park Calle B, Lote #20 ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: 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: EEO is the Law link - Espanol: 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